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AzTrials

Nodular Lymphocyte Predominant B-Cell LymphomaPhase 2NCT05886036

Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Bone Marrow Biopsy in people with Nodular Lymphocyte Predominant B-Cell Lymphoma and Recurrent Nodular Lymphocyte Predominant B-Cell Lymphoma, run by National Cancer Institute (NCI) at 37 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase II trial compares mosunetuzumab to the usual treatment (rituximab) for improving survival in patients with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). Rituximab and mosunetuzumab are monoclonal antibodies. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy Procedure, Biospecimen Collection and Bone Marrow Biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
37 sitesin 2 countries
Study dates
23 Jan 2024to 31 Oct 2028
Phase
Phase 2
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

  • Histopathologically confirmed diagnosis of NLPHL as confirmed by local pathologist's expert review.
  • Untreated NLPHL: stage IB to IV according to Cotswolds. The proportion of patients with stages I or II treated with consolidative radiotherapy will be capped at 40%.
  • Previously treated NLPHL, any stage.
  • According to the treating physician, the patient should not be observed and needs therapy, notably because of B-symptoms (unexplained fever [temperature > 38 degrees Celsius (> 100.4 degrees Fahrenheit)], weight loss [unexplained loss of > 10 percent of body weight over the past six months], or drenching night sweats), symptomatic nodal or extranodal disease, or patient preferences.
  • Patients must have measurable disease according to the Lugano/Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) classification.
  • Age >= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of mosunetuzumab in patients < 18 years of age, children are excluded from this study.
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  • Eastern Cooperative Oncology Group performance status =< 2 (Karnofsky >= 60%).
  • Absolute neutrophil count >= 1,000/mcL.
  • Platelets >= 100,000/mcL.
  • Total bilirubin =< 1.5 institutional upper limit of normal (ULN), except in patients with Gilbert's syndrome as defined by > 80% unconjugated bilirubin.
  • Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine transaminase (ALT)(serum glutamic-pyruvic transaminase [SGPT]) =< 3 x institutional ULN.
  • Glomerular filtration rate (GFR) >= 40mL /min= GFR (mL/Min/1.73 m^2) * body surface area (BSA)/1.73.
  • Human immunodeficiency virus-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
  • The effects of mosunetuzumab on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal and/or barrier method of birth control; abstinence) (both hormonal and barrier method of birth control are required for participants in Canada) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of mosunetuzumab administration and 12 months after completion of rituximab administration.
  • Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Who cannot join

  • Classical Hodgkin lymphoma (cHL) or composite lymphoma.
  • Active transformed NLPHL, concerns of the treating physician of an active occult transformation or concerns of the treating physician that the patient needs cytotoxic therapy. Participants with a history of transformed NLPHL in complete remission for at least 2 years since completion of cytotoxic therapy are eligible
  • NLPHL relapse less than 6 months after rituximab or rituximab-containing therapy.
  • Patients who have not recovered from AEs due to prior anticancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia.
  • Patients who are receiving any other investigational agents.
  • Patients with central nervous system (CNS) involvement as a result of lymphoma.
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  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to mosunetuzumab or rituximab.
  • Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.
  • Pregnant women are excluded from this study because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with mosunetuzumab; breastfeeding should be discontinued if the mother is treated with mosunetuzumab or rituximab. These potential risks may also apply to other agents used in this study.
  • Prior allogeneic stem cell or solid organ transplantation.
  • Participants who have received a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live, attenuated vaccine will be required during the study. Participants must not receive live, attenuated vaccines (e.g., FluMist [registered trademark]) while receiving study treatment and after the last dose until B-cell recovery to the normal ranges. Killed vaccines or toxoids should be given at least 4 weeks prior to the first dose of study treatment to allow development of sufficient immunity.
  • Any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment.
  • Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results as judged by the investigator, including, but not limited to:
  • Significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina).
  • Significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm).
  • Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
  • Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 1 year and have no residual neurologic deficits as judged by the investigator are allowed.
  • Participants with a history of epilepsy who have had no seizures in the past 2 years with or without anti-epileptic medications can be eligible only for the expansion cohort.
  • History of confirmed progressive multifocal leukoencephalopathy (PML).
  • Participants with infections requiring IV treatment with antibiotics or hospitalization (grade 3 or 4) within the last 4 weeks prior to enrollment or known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment.
  • Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to first dose of study treatment.
  • Known or suspected chronic active Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection.
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).

Trial locations and contacts

37 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

37 sites in 2 countries

United States36 sites, 33 recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Active, not recruiting

  • UM Sylvester Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

    Site Public Contact, 954-461-2180

    Michele Stanchina

    Recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Site Public Contact, 212-639-7592

    Raphael E. Steiner

    Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu

    Nathan L. Roberts

    Recruiting

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

    Site Public Contact, 513-584-7698, cancer@uchealth.com

    Zulfa Omer

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Yun Choi

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Site Public Contact, 212-639-7592

    Raphael E. Steiner

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

    Site Public Contact, 305-243-2647

    Michele Stanchina

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Springs

    Coral Springs, Florida, 33065

    Site Public Contact, 305-243-2647

    Michele Stanchina

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

    Site Public Contact, 305-243-2647

    Michele Stanchina

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Doral

    Doral, Florida, 33166

    Site Public Contact, kginnity@med.miami.edu

    Michele Stanchina

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Site Public Contact, 800-826-4673, becomingapatient@coh.org

    Alex F. Herrera

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Site Public Contact, 212-639-7592

    Raphael E. Steiner

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Hollywood

    Hollywood, Florida, 33021

    Site Public Contact, 305-243-2647

    Michele Stanchina

    Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Dai Chihara

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Marc S. Hoffmann

    Recruiting

  • University of Kansas Cancer Center - Briarcliff

    Kansas City, Missouri, 64116

    Site Public Contact, 913-588-3671

    Marc S. Hoffmann

    Recruiting

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Marc S. Hoffmann

    Recruiting

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Marc S. Hoffmann

    Recruiting

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

    Site Public Contact, 305-243-2647

    Michele Stanchina

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176

    Site Public Contact, 305-243-2647

    Michele Stanchina

    Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

    Site Public Contact, 212-639-7592

    Raphael E. Steiner

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Site Public Contact, 212-639-7592

    Raphael E. Steiner

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Site Public Contact, 212-639-7592

    Raphael E. Steiner

    Recruiting

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri, 64116

    Suspended

  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

    North Miami, Florida, 33181

    Site Public Contact, kginnity@med.miami.edu

    Michele Stanchina

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Sami Ibrahimi

    Recruiting

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Marc S. Hoffmann

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Active, not recruiting

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

    Site Public Contact, 305-243-2647

    Michele Stanchina

    Recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Site Public Contact, 804-628-6430, CTOclinops@vcu.edu

    Bruce O. Hough

    Recruiting

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

    Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu

    Allison Bock

    Recruiting

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

    Site Public Contact, 212-639-7592

    Raphael E. Steiner

    Recruiting

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio, 45069

    Site Public Contact, 513-584-7698, cancer@uchealth.com

    Zulfa Omer

    Recruiting

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Marc S. Hoffmann

    Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Site Public Contact, 336-713-6771

    Rakhee Vaidya

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

    Site Public Contact, 416-946-4501, clinical.trials@uhn.on.ca

    Anca Prica

    Recruiting

Other trials in Canada

About this study

Official title: NORM: Nodular Lymphocyte-Predominant Hodgkin Lymphoma Patients Treated in a Randomized Phase 2 Trial With Either Rituximab or Mosunetuzumab

This phase II trial compares mosunetuzumab to the usual treatment (rituximab) for improving survival in patients with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). Rituximab and mosunetuzumab are monoclonal antibodies. They bind 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. Mosunetuzumab may be more effective at extending survival in patients with NLPHL than the usual approach with rituximab.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare the progression-free survival (PFS) of mosunetuzumab versus rituximab in NLPHL patients.

SECONDARY OBJECTIVES:

  1. To compare the safety and antitumor activity of NLPHL patients treated with mosunetuzumab versus rituximab.

II. To evaluate the molecular effects of mosunetuzumab and rituximab on tumor cells and the immune response and identify biomarkers of response or resistance with ribonucleic acid sequencing (RNAseq), whole exome sequencing (WES), immunohistochemistry (IHC) CD20, PD-1, PD-L1, PD-L2.

III. To evaluate tumor microenvironment and peripheral immune status with single-cell ribonucleic acid sequencing (scRNA-seq).

EXPLORATORY OBJECTIVES:

  1. To evaluate CD20 expression and correlate with response. II. To evaluate the dynamic molecular response of NLPHL patients treated with rituximab or mosunetuzumab with circulating tumor deoxyribonucleic acid (ctDNA).

III. To evaluate the safety and efficacy (including tumor response, immune response, and overall survival) of the crossover patients.

IV. To assess the association of baseline fludeoxyglucose F-18 (FDG)-positron emission tomography/computed tomography (PET/CT) measurements including metabolic tumor volume (MTV) and maximum standardized uptake value (SUVmax), in combination with other risk factors, with PFS and overall survival (OS) in patients with lymphocyte-predominant Hodgkin lymphoma treated with mosunetuzumab or rituximab.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive mosunetuzumab subcutaneously (SC) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients who experience progressive disease (PD) will be permitted to crossover to arm II at week 12. Patients also receive FDG and undergo PET/CT at baseline and end of treatment. Patients who are positive at pre-treatment bone marrow biopsy also receive FDG and undergo PET/CT on study. Patients also undergo bone marrow biopsy and tissue biopsy at baseline, and blood sample collection throughout the trial. Patients may also undergo bone marrow biopsy and tissue biopsy at end of treatment.

ARM II: Patients receive rituximab intravenously (IV) on day 1 and rituximab and hyaluronidase human SC on days 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 2 cycles 8 weeks apart in the absence of disease progression or unacceptable toxicity. Patients may receive rituximab IV on days 8, 15, and 22 of each cycle if rituximab and hyaluronidase human is not available. Patients who experience PD will be permitted to crossover to arm I at week 12. Patients also receive FDG and undergo PET/CT at baseline and end of treatment. Patients who are positive at pre-treatment bone marrow biopsy also receive FDG and undergo PET/CT on study. Patients also undergo bone marrow biopsy and tissue biopsy at baseline, and blood sample collection throughout the trial. Patients may also undergo bone marrow biopsy and tissue biopsy at end of treatment.

After completion of study treatment, patients are followed up every 6 months for 2 years.

Being tested
Biopsy Procedure, Biospecimen Collection, Bone Marrow Biopsy, Computed Tomography, Fludeoxyglucose F-18

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo tissue biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow

    Undergo bone marrow biopsy

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT

  • Fludeoxyglucose F-18Other

    Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18

    Receive FDG

  • MosunetuzumabBiological

    Also called Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody BTCT4465A, BTCT 4465A, BTCT-4465A, BTCT4465A

    Given SC

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • 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

Study groups in NCT05886036
Study groupRoleWhat they receive
Arm I (Mosunetuzumab)ExperimentalPatients receive mosunetuzumab SC on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients who experience PD will be permitted to crossover to arm II at week 12. Patients also receive FDG and undergo PET/CT at baseline and end of treatment. Patients who are positive at pre-treatment bone marrow biopsy also receive FDG and undergo PET/CT on study. Patients also undergo bone marrow biopsy and tissue biopsy at baseline, and blood sample collection throughout the trial. Patients may also undergo bone marrow biopsy and tissue biopsy at end of treatment.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Other: Fludeoxyglucose F-18; Biological: Mosunetuzumab; Procedure: Positron Emission Tomography
Arm II (Rituximab, Rituximab and hyaluronidase human)Active comparatorPatients receive rituximab IV on day 1 and rituximab and hyaluronidase human SC on days 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 2 cycles 8 weeks apart in the absence of disease progression or unacceptable toxicity. Patients may receive rituximab IV on days 8, 15, and 22 of each cycle if rituximab and hyaluronidase human is not available. Patients who experience PD will be permitted to crossover to arm I at week 12. Patients also receive FDG and undergo PET/CT at baseline and end of treatment. Patients who are positive at pre-treatment bone marrow biopsy also receive FDG and undergo PET/CT on study. Patients also undergo bone marrow biopsy and tissue biopsy at baseline, and blood sample collection throughout the trial. Patients may also undergo bone marrow biopsy and tissue biopsy at end of treatment.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Other: Fludeoxyglucose F-18; Procedure: Positron Emission Tomography; Biological: Rituximab; Biological: Rituximab and Hyaluronidase Human

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) time

    Will be assessed according to the Lugano/Lymphoma Response to Immunomodulatory Therapy Criteria classification. The overall PFS curve will be displayed by treatment arm using the Kaplan-Meier (KM) method, and statistical comparisons will be performed by a log-rank test.

    Measured: Time from the date of randomization to the first objective documentation of disease progression or death due to any cause, assessed up to 2 years

Secondary outcomes (3)

  1. Objective response

    The count and incidence rate of the response categories will be summarized for the overall population and by each treatment arm with a 95% exact confidence intervals. Comparison between treatment arms will be performed by a chi-squared test.

    Measured: At week 12 and end of treatment

  2. Duration of response

    Will be displayed by treatment arm using the KM method, and statistical comparisons will be performed by a log-rank test.

    Measured: Time from the first date of partial or complete response until death or the assessment date of disease progression, assessed up to 2 years

  3. Overall survival (OS)

    Will be displayed by randomized treatment arm using the KM method, and statistical comparisons will be performed by a log-rank test.

    Measured: Time from the date of randomization to death due to any cause, assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start23 Jan 2024
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05886036
Sponsor's protocol ID
NCI-2023-04108
Other IDs
NCI-2023-04108, 10590, 10590, UM1CA186691
Status last verified
Oct 2026
First submitted
1 Jun 2023
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: "NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page."

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Bone Marrow Biopsy in people with Nodular Lymphocyte Predominant B-Cell Lymphoma and Recurrent Nodular Lymphocyte Predominant B-Cell Lymphoma, run by National Cancer Institute (NCI) at 37 sites in 2 countries.

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 19 inclusion and 23 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 14 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 37 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 (time frame: Time from the date of randomization to the first objective documentation of disease progression or death due to any cause, assessed up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05886036.

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 14 Oct 2026.

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