Richter SyndromePhase 3NCT07220187
Adding Pirtobrutinib to the Usual Treatment for People With Newly Diagnosed Richter Transformation, The PIRAMID Trial
A Phase 3 study testing Biospecimen Collection, Computed Tomography and Cyclophosphamide in people with Richter Syndrome and Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma, run by SWOG Cancer Research Network at 62 sites in United States.
Trial summary
This phase III trial compares the effect of adding pirtobrutinib to the usual treatment with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) to R-CHOP alone for the treatment of Richter transformation, which is when chronic lymphocytic leukemia or small lymphocytic lymphoma turns into… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Richter Syndrome, Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma, Transformed Small Lymphocytic Lymphoma to Diffuse Large B-Cell Lymphoma
- What is being tested?
- Biospecimen Collection, Computed Tomography and Cyclophosphamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 62 sitesUnited States
- Study dates
- 4 Aug 2026to Oct 2036
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have been diagnosed with Richter Transformation (RT) (CLL/small lymphocytic lymphoma [SLL] to LBCL)
- Participants must have histologically or cytologically confirmed LBCL
- Participants must have measurable disease determined by PET/CT or hematopathology (by morphology or flow cytometry) assessment within 42 days prior to registration
- Participants must have staging PET/CT imaging performed within 42 days prior to registration
- Participants are allowed prior treatments for CLL/SLL or its complications (autoimmune hemolytic anemia [AIHA], immune thrombocytopenic purpura [ITP]), with the exception of pirtobrutinib
- Participants must not have prior treatment for Richter transformation except for corticosteroids up to equivalent dose of prednisone 700 mg total for less than 7 days for disease control. Treatment for CLL/SLL with CLL/SLL directed drugs (including BTK inhibitors with the exception of pirtobrutinib) after the Richter transformation diagnosis is allowed for the purpose of disease control. CLL targeted therapies must be stopped within 3 days before initiation of therapy on protocol. Chemotherapy or anti-CD20 monoclonal antibody therapy must be stopped within 2 weeks before initiation of therapy on protocol
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- Participants must not have contraindication for receiving anthracycline. Participants must not have received more than a cumulative dose of 100mg/m^2 in those participants who will receive R-CHOP or not more than 250 mg/m^2 in those participants who will receive R-mini-CHOP of prior doxorubicin (or equivalent dose of another anthracycline, such as epirubicin) therapy (at any time prior to registration)
- Patients requiring strong CYP3A inducers are not eligible and can only be enrolled if
- an alternative treatment to the strong CYP3A inducer is available for them and
- the last dose of the strong CYP3A inducer is administered at least 7 days before initiation of pirtobrutinib for patients in safety run-in and arm 1
- Participant must be ≥ 18 years old at the time of registration
- Participant must have Eastern Cooperative Oncology Group (ECOG)/Zubrod Performance Status of 0-2
- Participant must have a complete medical history and physical exam within 28 days prior to registration
- Absolute neutrophil count (ANC) ≥ 0.75 x 10^3/µL or ≥ 0.50 x 10^3/µL in participants with suspected marrow involvement considered to impair hematopoiesis (within 28 days prior to registration)
- Platelets ≥ 50 x 10^3/µL or ≥ 30 x 10^3/µL in participants with suspected marrow involvement considered to impair hematopoiesis (within 28 days prior to registration)
- Hemoglobin ≥ 8 g/dL (≥ 80 g/L) or ≥ 6 g/dL in participants with suspected bone marrow involvement considered to impair hematopoiesis (within 28 days prior to registration)
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or ≤ 3 x ULN with documented liver involvement and/or Gilbert's disease (within 28 days prior to registration)
- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 3 × institutional ULN or ≤ 5 ULN with documented liver involvement (within 28 days prior to registration)
- Participants must have a calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration. For the Cockcroft-Gault formula for calculated creatinine clearance, see the tools on the CRA Workbench https://txwb.crab.org/TXWB/Tools.aspx
- Participants must have a left ventricular ejection fraction (LVEF) ≥ 45% as measured by echocardiogram or radionuclide (MUGA) ventriculography within 56 days prior to registration
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Participants' HIV-directed therapy cannot have known interactions with pirtobrutinib
- Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration
- Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration
- Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications
- Participants must not have a prior or concurrent malignancy in addition to CLL/SLL and Richter transformation whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- Participants must not have had major surgery within 28 days prior to registration
- Participants must not have experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor.
- NOTE: Major bleeding is defined as bleeding having one or more of the following features: potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2g per deciliter; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome
- Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
- Participants must be offered the opportunity to participate in specimen banking
- Participants must agree to have blood and lymphatic tissue specimens submitted for the integrated translational medicine study
- For randomized participants only: Participants who can complete PRO-CTCAE and FACIT GP5 questionnaires forms in English or Spanish must be offered the opportunity to participate in the patient-reported outcome
Who cannot join
None listed.
Trial locations and contacts
62 sites in 1 country. Contact the study team or a site near you to ask about taking part.
62 sites in 1 country
United States62 sites, 62 recruiting
- Recruiting
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
Site Public Contact, 225-765-7659, research@ololrmc.com
Nakhle S. Saba
- Recruiting
FHCC Overlake
Bellevue, Washington, 98004
Site Public Contact, 425-454-2148
Jason Comer
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Christopher E. Jensen
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Dilan A. Patel
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Dilan A. Patel
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Andrea Sitlinger
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Catherine C. Coombs
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
FHCC at EvergreenHealth
Kirkland, Washington, 98034
Site Public Contact, 425-899-6000
Vikram Raghunathan
- Recruiting
UCI Health Laguna Hills
Laguna Hills, California, 92653
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Catherine C. Coombs
- Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
Site Public Contact, 262-257-5100
Gulrayz Ahmed
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Gulrayz Ahmed
- Recruiting
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
Site Public Contact, research.institute@phci.org
Timothy R. Wassenaar
- Recruiting
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, 53151
Site Public Contact, 414-805-0505
Gulrayz Ahmed
- Recruiting
Carle BroMenn Medical Center
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Carle Cancer Institute Normal
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
Site Public Contact, 414-805-0505
Gulrayz Ahmed
- Recruiting
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
Site Public Contact, 262-928-7878
Timothy R. Wassenaar
- Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Catherine C. Coombs
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peru
Peru, Illinois, 61354
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Michael Wysota
- Recruiting
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Site Public Contact, ctoclinops@vcu.edu
Victor Y. Yazbeck
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Victor Y. Yazbeck
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Boyu Hu
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Site Public Contact, 800-804-8824
Mazyar Shadman
- Recruiting
FHCC at Northwest Hospital
Seattle, Washington, 98133
Site Public Contact, 206-606-5800
Paul S. Martin
- Recruiting
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
Site Public Contact, 800-804-8824
Mazyar Shadman
- Recruiting
Memorial Hospital East
Shiloh, Illinois, 62269
Site Public Contact, 314-747-9912, dschwab@wustl.edu
Dilan A. Patel
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Site Public Contact, 217-545-7929
Bryan A. Faller
- Recruiting
Springfield Clinic
Springfield, Illinois, 62702
Site Public Contact, 800-444-7541
Bryan A. Faller
- Recruiting
Springfield Memorial Hospital
Springfield, Illinois, 62781
Site Public Contact, 217-528-7541, pallante.beth@mhsil.com
Bryan A. Faller
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Dilan A. Patel
- Recruiting
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Dilan A. Patel
- Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Dilan A. Patel
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Illinois CancerCare - Washington
Washington, Illinois, 61571
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
Site Public Contact, 262-928-7632
Timothy R. Wassenaar
- Recruiting
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
Site Public Contact, 262-928-5539, Chanda.miller@phci.org
Timothy R. Wassenaar
- Recruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095
Site Public Contact, 414-805-0505
Gulrayz Ahmed
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
About this study
Official title: A Randomized Phase III Study of Pirtobrutinib Plus R-CHOP vs. R-CHOP for Participants With Previously Untreated Richter Transformation (PIRAMID)
This phase III trial compares the effect of adding pirtobrutinib to the usual treatment with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) to R-CHOP alone for the treatment of Richter transformation, which is when chronic lymphocytic leukemia or small lymphocytic lymphoma turns into large B-cell lymphoma, a more aggressive (faster-growing) form of lymphoma. Pirtobrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Adding pirtobrutinib to R-CHOP may kill more cancer cells than R-CHOP alone in patients with Richter transformation.
Read the detailed description
PRIMARY OBJECTIVES:
- In participants aged 74 and younger, to evaluate the safety of the addition of pirtobrutinib to R-CHOP before initiating randomization in participants with untreated Richter Transformation to large B-cell lymphoma (LBCL). (Safety run-in) II. In participants aged 75 and older, to evaluate the safety of the addition of pirtobrutinib to R-mini-CHOP before initiating randomization in this patient population. (Safety run-in) III. To evaluate whether the addition of pirtobrutinib to R-CHOP improves investigator-assessed progression-free survival (PFS) compared to R-CHOP alone in this patient population. (Randomized comparison) IV. If investigator-assessed PFS is improved with the addition of pirtobrutinib, then to evaluate whether the addition of pirtobrutinib improves overall survival (OS) in this patient population. (Randomized comparison-hierarchical testing)
TRANSLATIONAL MEDICINE PRIMARY OBJECTIVE:
- To evaluate the association between high-risk Richter-associated mutations (presence vs. absence of at least one of: TP53, CDK2NA, or MYC pathway alterations as assessed by targeted next generation sequencing (NGS) panel and whole exome sequencing of baseline tumor tissue) and overall survival (OS) within treatment arms in this patient population.
SECONDARY OBJECTIVES:
- To estimate and compare the rate of investigator-assessed complete response (CR) after treatment between the randomized arms.
II. To estimate the frequency and severity of adverse events in both arms.
TRANSLATIONAL MEDICINE SECONDARY OBJECTIVES:
- To evaluate the association between high-risk Richter-associated mutations and overall response rate (ORR [complete and partial response], PFS and complete response [CR]) across treatment arms in this patient population.
II. To descriptively report the interaction between high-risk Richter-associated mutations and randomized arm and the outcomes CR, ORR, PFS, and OS.
III. To descriptively report the mutational landscape (as assessed by targeted NGS panel and whole exome sequencing of baseline tumor tissue and at the time of progression) in this patient population.
IV. In mutations present in at least 5 patients, to descriptively report CR, ORR, PFS, and OS by mutation status across treatment arms.
- To evaluate associations between minimal residual disease (MRD) status (as assessed by circulating tumor deoxyribonucleic acid [ctDNA]) and OS and PFS.
VI. To evaluate associations between clonal relatedness and OS and PFS across treatment arms.
ADDITIONAL OBJECTIVES:
- To compare OS of participants receiving stem cell transplant versus those who did not receive transplant.
II. To compare the OS of participants receiving chimeric antigen receptor t cell (CAR-T) therapy versus those who did not receive CAR-T therapy.
III. To evaluate the association between Bruton Tyrosine Kinase (BTK) resistance mutations on clinical outcomes (PFS and OS).
IV. To evaluate the association of clonal relatedness between chronic lymphocytic leukemia (CLL) and LBCL and clinical outcomes (PFS and OS).
PATIENT-REPORTED OUTCOMES OBJECTIVE:
- To compare participant-reported symptoms (PROs) between arms as measured by PRO-Common Terminology Criteria for Adverse Events (CTCAE) items and the Functional Assessment of Chronic Illness Therapy (FACIT) single-item GP5 question.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive pirtobrutinib orally (PO) once daily (QD) on days 1-21 of each cycle, rituximab intravenously (IV) or rituximab and hyaluronidase human (rituximab hyaluronidase) subcutaneously (SC) (starting with cycle 2), cyclophosphamide IV on day 1 of each cycle, doxorubicin IV on day 1 of each cycle, vincristine IV on day 1 of each cycle, and prednisone PO QD on days 1-5 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients continue to receive pirtobrutinib PO QD on days 1-21 of each cycle for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients with progressive disease or symptomatic deterioration may receive 1 additional cycle as long as the participant is continuing to clinically benefit from treatment in the opinion of the treating investigator. Patients undergo echocardiography or multigated acquisition (MUGA) scan and buccal swab collection during screening, as well as computed tomography (CT) scan and/or positron emission tomography (PET)/CT, and blood sample collection throughout the study.
ARM 2: Patients receive rituximab IV or rituximab hyaluronidase SC (starting with cycle 2), cyclophosphamide IV on day 1 of each cycle, doxorubicin IV on day 1 of each cycle, vincristine IV on day 1 of each cycle, and prednisone PO QD on days 1-5 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan and buccal swab collection during screening, as well as CT scan and/or PET, and blood sample collection throughout the study.
After completion of study treatment, patients are followed up periodically for until 7 years after registration.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood and buccal swab sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT scan and/or PET/CT scan
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518
Given IV
Also called 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin
Given IV
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo echocardiography
Multigated Acquisition ScanProcedure or surgery
Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan
Undergo MUGA scan
PirtobrutinibDrug
Also called 5-Amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-((2S)-1,1,1-trifluoropropan-2-yl)-1h-pyrazole-4-carboxamide, BTK Inhibitor LOXO-305, Jaypirca, LOXO 305
Given PO
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT scan
PrednisoneDrug
Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl
Given PO
RituximabBiological
Also called ABP 798, ABP-798, ABP798, BI 695500
Given IV
Rituximab and Hyaluronidase HumanBiological
Also called Rituxan Hycela, Rituximab Plus Hyaluronidase, Rituximab/Hyaluronidase, Rituximab/Hyaluronidase Human
Given SC
Survey AdministrationOther
Ancillary studies
VincristineDrug
Also called LCR, Leurocristine, VCR, Vincrystine
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (pirtobrutinib and R-CHOP) | Experimental | Patients receive pirtobrutinib PO QD on days 1-21 of each cycle, rituximab IV or rituximab hyaluronidase SC (starting with cycle 2), cyclophosphamide IV on day 1 of each cycle, doxorubicin IV on day 1 of each cycle, vincristine IV on day 1 of each cycle, and prednisone PO QD on days 1-5 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients continue to receive pirtobrutinib PO QD on days 1-21 of each cycle for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients with progressive disease or symptomatic deterioration may receive 1 additional cycle as long as the participant is continuing to clinically benefit from treatment in the opinion of the treating investigator. Patients undergo echocardiography or MUGA scan and buccal swab collection during screening, as well as CT scan and/or PET/CT, and blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride; Procedure: Echocardiography Test; Procedure: Multigated Acquisition Scan; Drug: Pirtobrutinib; Procedure: Positron Emission Tomography; Drug: Prednisone; Biological: Rituximab; Biological: Rituximab and Hyaluronidase Human; Other: Survey Administration; Drug: Vincristine |
| Arm II (R-CHOP) | Active comparator | Patients receive rituximab IV or rituximab hyaluronidase SC (starting with cycle 2), cyclophosphamide IV on day 1 of each cycle, doxorubicin IV on day 1 of each cycle, vincristine IV on day 1 of each cycle, and prednisone PO QD on days 1-5 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan and buccal swab collection during screening, as well as CT scan and/or PET, and blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride; Procedure: Echocardiography Test; Procedure: Multigated Acquisition Scan; Procedure: Positron Emission Tomography; Drug: Prednisone; Biological: Rituximab; Biological: Rituximab and Hyaluronidase Human; Other: Survey Administration; Drug: Vincristine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Progression free survival: is measured from date of randomization to the first of progression or death from any cause. Participants last known to be alive without progression will be censored at the date of last contact.
Measured: Up to 7 years
Overall free survival
Overall free survival: is measured from date of randomization date of death from any cause. Participants last known to be alive will be censored at the date of last contact.
Measured: Up to 7 years
Secondary outcomes (3)
Overall Response
Will estimate outcomes (CR, ORR, MRD) for each arm as proportions with binomial confidence intervals. Proportions will be compared between arms using Fisher's exact test.
Measured: Up to 7 years
Complete Remission
Complete disappearance of all measurable and non-measurable disease.
Measured: Up to 7 years
Incidence of adverse events
Number of patients with grade 3 through 5 adverse events that are related (possibly, probably, definitely) to protocol therapy
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2025
- Study start4 Aug 2026
- Primary completion1 Oct 2035 (estimated)
- Study completionOct 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Richter SyndromeStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mazyar Shadman, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220187
- Sponsor's protocol ID
- S2504
- Other IDs
- NCI-2025-06717, S2504, S2504, U10CA180888
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study of Pirtobrutinib Plus R-CHOP vs. R-CHOP for Participants With Previously Untreated Richter Transformation (PIRAMID)
- ClinicalTrials.gov ID
- NCT07220187
- Acronym / sponsor ID
- S2504
- Conditions
- Richter Syndrome, Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma, Transformed Small Lymphocytic Lymphoma to Diffuse Large B-Cell Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 1 Oct 2035 (estimated)
- Study completion
- Oct 2036 (estimated)
- First posted
- 23 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase III trial compares the effect of adding pirtobrutinib to the usual treatment with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) to R-CHOP alone for the treatment of Richter transformation, which is when chronic lymphocytic leukemia or small lymphocytic lymphoma turns into large B-cell lymphoma, a more aggressive (faster-growing) form of lymphoma. Pirtobrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Adding pirtobrutinib to R-CHOP may kill more cancer cells than R-CHOP alone in patients with Richter transformation.
Detailed description
PRIMARY OBJECTIVES:
- In participants aged 74 and younger, to evaluate the safety of the addition of pirtobrutinib to R-CHOP before initiating randomization in participants with untreated Richter Transformation to large B-cell lymphoma (LBCL). (Safety run-in) II. In participants aged 75 and older, to evaluate the safety of the addition of pirtobrutinib to R-mini-CHOP before initiating randomization in this patient population. (Safety run-in) III. To evaluate whether the addition of pirtobrutinib to R-CHOP improves investigator-assessed progression-free survival (PFS) compared to R-CHOP alone in this patient population. (Randomized comparison) IV. If investigator-assessed PFS is improved with the addition of pirtobrutinib, then to evaluate whether the addition of pirtobrutinib improves overall survival (OS) in this patient population. (Randomized comparison-hierarchical testing)
TRANSLATIONAL MEDICINE PRIMARY OBJECTIVE:
- To evaluate the association between high-risk Richter-associated mutations (presence vs. absence of at least one of: TP53, CDK2NA, or MYC pathway alterations as assessed by targeted next generation sequencing (NGS) panel and whole exome sequencing of baseline tumor tissue) and overall survival (OS) within treatment arms in this patient population.
SECONDARY OBJECTIVES:
- To estimate and compare the rate of investigator-assessed complete response (CR) after treatment between the randomized arms.
II. To estimate the frequency and severity of adverse events in both arms.
TRANSLATIONAL MEDICINE SECONDARY OBJECTIVES:
- To evaluate the association between high-risk Richter-associated mutations and overall response rate (ORR [complete and partial response], PFS and complete response [CR]) across treatment arms in this patient population.
II. To descriptively report the interaction between high-risk Richter-associated mutations and randomized arm and the outcomes CR, ORR, PFS, and OS.
III. To descriptively report the mutational landscape (as assessed by targeted NGS panel and whole exome sequencing of baseline tumor tissue and at the time of progression) in this patient population.
IV. In mutations present in at least 5 patients, to descriptively report CR, ORR, PFS, and OS by mutation status across treatment arms.
- To evaluate associations between minimal residual disease (MRD) status (as assessed by circulating tumor deoxyribonucleic acid [ctDNA]) and OS and PFS.
VI. To evaluate associations between clonal relatedness and OS and PFS across treatment arms.
ADDITIONAL OBJECTIVES:
- To compare OS of participants receiving stem cell transplant versus those who did not receive transplant.
II. To compare the OS of participants receiving chimeric antigen receptor t cell (CAR-T) therapy versus those who did not receive CAR-T therapy.
III. To evaluate the association between Bruton Tyrosine Kinase (BTK) resistance mutations on clinical outcomes (PFS and OS).
IV. To evaluate the association of clonal relatedness between chronic lymphocytic leukemia (CLL) and LBCL and clinical outcomes (PFS and OS).
PATIENT-REPORTED OUTCOMES OBJECTIVE:
- To compare participant-reported symptoms (PROs) between arms as measured by PRO-Common Terminology Criteria for Adverse Events (CTCAE) items and the Functional Assessment of Chronic Illness Therapy (FACIT) single-item GP5 question.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive pirtobrutinib orally (PO) once daily (QD) on days 1-21 of each cycle, rituximab intravenously (IV) or rituximab and hyaluronidase human (rituximab hyaluronidase) subcutaneously (SC) (starting with cycle 2), cyclophosphamide IV on day 1 of each cycle, doxorubicin IV on day 1 of each cycle, vincristine IV on day 1 of each cycle, and prednisone PO QD on days 1-5 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients continue to receive pirtobrutinib PO QD on days 1-21 of each cycle for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients with progressive disease or symptomatic deterioration may receive 1 additional cycle as long as the participant is continuing to clinically benefit from treatment in the opinion of the treating investigator. Patients undergo echocardiography or multigated acquisition (MUGA) scan and buccal swab collection during screening, as well as computed tomography (CT) scan and/or positron emission tomography (PET)/CT, and blood sample collection throughout the study.
ARM 2: Patients receive rituximab IV or rituximab hyaluronidase SC (starting with cycle 2), cyclophosphamide IV on day 1 of each cycle, doxorubicin IV on day 1 of each cycle, vincristine IV on day 1 of each cycle, and prednisone PO QD on days 1-5 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan and buccal swab collection during screening, as well as CT scan and/or PET, and blood sample collection throughout the study.
After completion of study treatment, patients are followed up periodically for until 7 years after registration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (pirtobrutinib and R-CHOP) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Procedure: Echocardiography Test, Procedure: Multigated Acquisition Scan, Drug: Pirtobrutinib, Procedure: Positron Emission Tomography, Drug: Prednisone, Biological: Rituximab, Biological: Rituximab and Hyaluronidase Human, Other: Survey Administration, Drug: VincristinePatients receive pirtobrutinib PO QD on days 1-21 of each cycle, rituximab IV or rituximab hyaluronidase SC (starting with cycle 2), cyclophosphamide IV on day 1 of each cycle, doxorubicin IV on day 1 of each cycle, vincristine IV on day 1 of each cycle, and prednisone PO QD on days 1-5 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients continue to receive pirtobrutinib PO QD on days 1-21 of each cycle for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients with progressive disease or symptomatic deterioration may receive 1 additional cycle as long as the participant is continuing to clinically benefit from treatment in the opinion of the treating investigator. Patients undergo echocardiography or MUGA scan and buccal swab collection during screening, as well as CT scan and/or PET/CT, and blood sample collection throughout the study. |
| Arm II (R-CHOP) | Active comparator | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Procedure: Echocardiography Test, Procedure: Multigated Acquisition Scan, Procedure: Positron Emission Tomography, Drug: Prednisone, Biological: Rituximab, Biological: Rituximab and Hyaluronidase Human, Other: Survey Administration, Drug: VincristinePatients receive rituximab IV or rituximab hyaluronidase SC (starting with cycle 2), cyclophosphamide IV on day 1 of each cycle, doxorubicin IV on day 1 of each cycle, vincristine IV on day 1 of each cycle, and prednisone PO QD on days 1-5 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan and buccal swab collection during screening, as well as CT scan and/or PET, and blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Participants must have been diagnosed with Richter Transformation (RT) (CLL/small lymphocytic lymphoma [SLL] to LBCL)
- Participants must have measurable disease determined by PET/CT or hematopathology (by morphology or flow cytometry) assessment within 42 days prior to registration
- Participants must have staging PET/CT imaging performed within 42 days prior to registration
- Participants are allowed prior treatments for CLL/SLL or its complications (autoimmune hemolytic anemia [AIHA], immune thrombocytopenic purpura [ITP]), with the exception of pirtobrutinib
- Participants must not have prior treatment for Richter transformation except for corticosteroids up to equivalent dose of prednisone 700 mg total for less than 7 days for disease control. Treatment for CLL/SLL with CLL/SLL directed drugs (including BTK inhibitors with the exception of pirtobrutinib) after the Richter transformation diagnosis is allowed for the purpose of disease control. CLL targeted therapies must be stopped within 3 days before initiation of therapy on protocol. Chemotherapy or anti-CD20 monoclonal antibody therapy must be stopped within 2 weeks before initiation of therapy on protocol
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood and buccal swab sample collection | Procedure or surgery | Arm I (pirtobrutinib and R-CHOP), Arm II (R-CHOP) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT scan and/or PET/CT scan | Procedure or surgery | Arm I (pirtobrutinib and R-CHOP), Arm II (R-CHOP) |
| CyclophosphamideAlso: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518Given IV | Drug | Arm I (pirtobrutinib and R-CHOP), Arm II (R-CHOP) |
| Doxorubicin HydrochlorideAlso: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, AdriamycinGiven IV | Drug | Arm I (pirtobrutinib and R-CHOP), Arm II (R-CHOP) |
| Echocardiography TestAlso: EC, EchocardiographyUndergo echocardiography | Procedure or surgery | Arm I (pirtobrutinib and R-CHOP), Arm II (R-CHOP) |
| Multigated Acquisition ScanAlso: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool ScanUndergo MUGA scan | Procedure or surgery | Arm I (pirtobrutinib and R-CHOP), Arm II (R-CHOP) |
| PirtobrutinibAlso: 5-Amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-((2S)-1,1,1-trifluoropropan-2-yl)-1h-pyrazole-4-carboxamide, BTK Inhibitor LOXO-305, Jaypirca, LOXO 305Given PO | Drug | Arm I (pirtobrutinib and R-CHOP) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT scan | Procedure or surgery | Arm I (pirtobrutinib and R-CHOP), Arm II (R-CHOP) |
| PrednisoneAlso: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, CortancylGiven PO | Drug | Arm I (pirtobrutinib and R-CHOP), Arm II (R-CHOP) |
| RituximabAlso: ABP 798, ABP-798, ABP798, BI 695500Given IV | Biological | Arm I (pirtobrutinib and R-CHOP), Arm II (R-CHOP) |
| Rituximab and Hyaluronidase HumanAlso: Rituxan Hycela, Rituximab Plus Hyaluronidase, Rituximab/Hyaluronidase, Rituximab/Hyaluronidase HumanGiven SC | Biological | Arm I (pirtobrutinib and R-CHOP), Arm II (R-CHOP) |
| Survey AdministrationAncillary studies | Other | Arm I (pirtobrutinib and R-CHOP), Arm II (R-CHOP) |
| VincristineAlso: LCR, Leurocristine, VCR, VincrystineGiven IV | Drug | Arm I (pirtobrutinib and R-CHOP), Arm II (R-CHOP) |
Primary outcome
Progression free survival (PFS)
Time frame: Up to 7 years
Progression free survival: is measured from date of randomization to the first of progression or death from any cause. Participants last known to be alive without progression will be censored at the date of last contact.
Overall free survival
Time frame: Up to 7 years
Overall free survival: is measured from date of randomization date of death from any cause. Participants last known to be alive will be censored at the date of last contact.
3 secondary outcomes
Overall Response
Time frame: Up to 7 years
Complete Remission
Time frame: Up to 7 years
Incidence of adverse events
Time frame: Up to 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, United States
Mazyar Shadman principal investigator
SWOG Cancer Research Network
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biospecimen Collection, Computed Tomography and Cyclophosphamide in people with Richter Syndrome and Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma, run by SWOG Cancer Research Network at 62 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Up to 7 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.