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AzTrials

AIDS-Related Diffuse Large B-cell LymphomaPhase 1NCT07649304

AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")

A Phase 1 study testing Biopsy Procedure, Biospecimen Collection and Bone Marrow Aspiration in people with AIDS-Related Diffuse Large B-cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, run by National Cancer Institute (NCI) at 1 site in United States.

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Sites and contacts
Official record
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Trial summary

This phase I trial studies the safety and side effects of glofitamab plus a chemoimmunotherapy regimen called R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in treating patients newly-diagnosed with HIV-associated large B-cell lymphoma. 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 Aspiration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
5 Jul 2027to 1 Dec 2028
Phase
Phase 1
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

  • Participant is able to understand and willing to sign a written informed consent document
  • Participants must have histologically (via at least a core or ideally, incisional or excisional biopsy) documented CD20 positive newly diagnosed HIV-associated LBCL as per World Health Organization (WHO) 5th edition, diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high grade B-cell lymphoma-NOS or DLBCL/high grade B-cell lymphoma with MYC and BCL2 rearrangement. Plasmablastic lymphoma and primary effusion lymphoma may be included only if CD20-positive
  • Stage II-IV disease (as per Lugano Staging Criteria) that is measurable as defined below:
  • Measurable lymph nodes with longest diameter > 1.5 cm, or
  • Measurable extranodal lesions with longest diameter > 1.0 cm
  • Participants with bone marrow involvement only will be eligible as long as the morphological bone marrow involvement is documented on a bone marrow biopsy. These participants, however, will need to be willing to undergo subsequent bone marrow biopsies for response assessment and documentation
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  • Evidence of HIV infection. Participants must have documentation of HIV-1 infection by means of any one of the following:
  • Documentation of HIV diagnosis in the medical record by a licensed health care provider;
  • Documentation of receipt of ART (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis) by a licensed health care provider. Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name;
  • HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay at any time;
  • Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.
  • Note: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., United States [US] Food and Drug Administration [FDA]).
  • World Health Organization and Centers for Disease Control and Prevention guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.
  • Participants with HIV must be on treatment with effective ART that is in accordance with the current International AIDS Society guidelines concurrently with chemotherapy. Use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) or ritonavir (includes Norvir® or Kaletra®), cobicistat, didanosine (Videx® or Videx EC®), or similar potent CYP3 inhibitors are prohibited. In order to be eligible, participants taking zidovudine or ritonavir, cobicistat, didanosine, or other CYP3 inhibitors must change to a different regimen 7 days prior to protocol therapy initiation. Changes to ART therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.). Participants must be on ART for at least 7 days prior to initiation of protocol therapy except for ART-naïve participants who need to get started on ART within the 1st cycle of study treatment (before cycle 2 day 1). ART needs to be approved by protocol chair or co-chair prior to enrollment
  • Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of glofitamab in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in participants < 18 years of age, children are excluded from this study
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥50%)
  • Absolute neutrophil count (ANC) ≥ 1,000/mcL unless decreased due to bone marrow involvement. Also, in participants with the Duffy antigen null phenotype, neutrophil counts may be lower and a lower threshold required for enrollment can be discussed with the protocol chair on a case-by-case basis
  • Platelets ≥ 75,000/mcL unless decreased due to bone marrow involvement
  • Hemoglobin of ≥ 8 g/dL unless decreased due to bone marrow involvement
  • Aspartate aminotransferase (AST [serum glutamic oxaloacetic transaminase (SGOT)])/alanine aminotransferase (ALT [serum glutamate pyruvate transaminase (SGPT)]) ≤ 3 × institutional upper limit of normal (ULN; ≤ 5 × ULN is acceptable if secondary to liver involvement by lymphoma)
  • Total serum bilirubin ≤ 1.5 × institutional ULN (< 3.0 × ULN for participants with Gilbert syndrome). If, however, the elevated bilirubin is felt to be secondary to ART, the total bilirubin must be ≤ 3.5 mg/dL, provided that the direct bilirubin is normal and the AST and ALT ≤ 3 x the ULN
  • Glomerular filtration rate (GFR) no lower than 30 mL/min/1.73 m^2. GFR can be measured directly or estimated using the site's institutional standards
  • Participants must have adequate cardiac function defined as a left ventricular ejection fraction of at least 45% as determined by echocardiogram or multigated acquisition within 6 weeks before enrollment
  • The effects of glofitamab on the developing human fetus are unknown. For this reason and because CD20/CD3 bispecific antibodies, as well as other therapeutic agents used in this trial, are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; total abstinence) from study entry and for at least 1 months from the last glofitamab administration or 12 months from the last rituximab administration, whichever is the longest. Women of childbearing potential, defined as pre- or perimenopausal females with an intact uterus, must have a negative serum β-HCG within 7 days prior to enrollment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately. Men treated with glofitamab must also agree to use adequate contraception with partners who are women of childbearing potential (condom plus an additional contraceptive method, such as bilateral tubal occlusion, male sterilization, hormone-releasing intrauterine devices, and copper intrauterine devices) or use contraceptive measures such as a condom with pregnant female partners to avoid exposing the embryo during intercourse, from study entry, for the duration of study participation, and 1 months after the last glofitamab dose or 12 months after completion of rituximab administration, whichever is the longest
  • Any CD4 count is allowed
  • Participants with leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required during the first cycle of therapy, except during the initial safety run-in phase, during which participants with leptomeningeal disease will be excluded. For the first three study participants, enrollment will be halted until the third participant completes two target doses (30 mg) of glofitamab and dose-limiting toxicity (DLT) assessment is completed
  • Participants 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

Who cannot join

  • Participants who are receiving any other investigational agents
  • Participants with active parenchymal central nervous system (CNS) lymphomatous involvement are excluded; however, asymptomatic leptomeningeal disease is allowed as long as participants have ongoing CNS directed therapy, except during the initial safety-run in phase, during which participants with leptomeningeal disease will also be excluded
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study
  • Uncontrolled intercurrent illness including, but not limited to: symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (including, but not limited to clinically significant obstructive pulmonary disease or history of bronchospasm), clinically significant liver disease (including viral or other hepatitis or cirrhosis) or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements or make participation in this protocol unreasonably hazardous
  • Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with the study agent(s), breastfeeding should be discontinued if the mother is treated with the study agent(s). These potential risks may also apply to other agents used in this study
  • Participants with refractory HIV disease will not be eligible. Refractory HIV will be defined as prior ART exposure and HIV viral load > 1000 copies/uL and no options for HIV control evaluated by HIV genotyping. Participants with HIV viral load > 1000 copies/uL can be enrolled if additional ART will be initiated
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  • Participants who have had chemotherapy other than allowable pre-trial therapy outlined below, or radiotherapy other than palliative radiation for medical emergencies (i.e., cord compression or impending fracture), within the last four weeks.
  • Allowable prior therapy:
  • A maximum of one cycle of combination chemotherapy, including CHOP ± rituximab and etoposide-prednisone-Oncovin-cyclophosphamide-hydroxydaunorubicin (EPOCH) ± rituximab. The start of previous chemotherapy cycle must occur at least 21 days but no more than 35 days prior to beginning treatment under this protocol, and this cycle will count towards the maximum of six cycles under this study (i.e., cycle received prior to study enrollment will count as cycle 1) OR
  • One prior course of limited therapy including cyclophosphamide and/or glucocorticoids and/or rituximab to improve fitness for combination chemotherapy (i.e., those with impaired hepatic function, renal function and or performance status due to lymphomatous involvement). The start of this therapy may occur up to 35 days prior to beginning treatment under this protocol; cyclophosphamide administration must have been completed at least 14 days prior to initiation of protocol therapy. Such treatment will not count towards the maximum of six cycles under this study (i.e., participants will receive six cycles on study and start with cycle 1 of RCHOP)
  • Participants must not have had previous anthracycline treatment within the last two years, except for one cycle off protocol or liposomal doxorubicin. Any prior exposure to liposomal doxorubicin is allowed as long as the left ventricular ejection fraction is ≥ 45%. It is at the discretion of the investigator if prior exposure to doxorubicin more than two years prior is acceptable
  • Known active bacterial, viral (HIV infection allowed), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or significant infections within 4 weeks before the start of cycle 1
  • Participants with chronic hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). All participants will be required to be screened for Hepatitis B. Participants with resolved infection (i.e., participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of Hepatitis B virus (HBV) DNA levels. Participants who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR. For participants who have evidence of prior Hepatitis B exposure and are PCR negative, hepatitis B (Hep B) reactivation prophylaxis is mandated using institutional guidelines
  • If hepatitis C antibody positive, participants will be excluded from study unless hepatitis C viral load is undetectable. Additionally, participants must have no evidence of cirrhosis and have liver function tests (LFTs)
  • Participants with baseline peripheral neuropathy > grade 2 or painful >/= grade 2 neuropathy
  • Participants who have not recovered from AEs due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia
  • Concomitant medications: Participants should only be excluded from trial participation when clinically relevant known or predicted drug-drug interactions or potential overlapping toxicities will impact safety or efficacy. Please include scientific or clinically based rationale for exclusion.
  • Please note that this must account for all agents to be used on this study, including commercial agents. Please refer to the FDA product labels for all commercial agents and include information on prohibited concomitant medications in all applicable sections of the protocol
  • A wash out period prior to the start of cycle 1 of at least 4 weeks for prior use of any monoclonal antibody, systemic immunotherapeutic agents, immunosuppressive agents (such as, but not limited to cyclosporin, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor) is required
  • Unable to comply with the requirements of the protocol, or unable to provide adequate informed consent in the opinion of the principal investigator (PI). Participants with impaired decision-making capacity (IDMC) with a legally authorized representative (LAR) may be included if they fulfill all other eligibility requirements."
  • Major surgery, other than diagnostic surgery, occurring within 4 weeks prior to study entry. Splenectomy will not be considered an exclusionary major surgery
  • Having received a live, attenuated vaccine within 28 days prior to registration
  • Myocardial infarction within the preceding 3 months
  • Prior solid organ or allogeneic hematopoietic cell transplant
  • Prior diagnosis of progressive multifocal leukoencephalopathy (PML)
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
  • History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. The following exceptions apply:
  • Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone
  • Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for study
  • Patients with a history of disease-related immune thrombocytopenic purpura, autoimmune hemolytic anemia, or other stable autoimmune diseases
  • Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
  • Rash must cover < 10% of body surface area
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • AIDS Malignancy Consortium

    Rockville, Maryland, 20850

    Stefan K. Barta, stefan.barta@pennmedicine.upenn.edu

    Stefan K. Barta

    Recruiting

Other trials in United States

About this study

Official title: A Feasibility Study of Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma

This phase I trial studies the safety and side effects of glofitamab plus a chemoimmunotherapy regimen called R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in treating patients newly-diagnosed with HIV-associated large B-cell lymphoma. Glofitamab is a bispecific monoclonal antibody, which can bind to two different antigens that are expressed by cancer cells (CD3 and CD20) at the same time. This may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. 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 deoxyribonucleic acid (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. Giving glofitamab in combination with the R-CHOP regimen may be a safe treatment for patients with newly-diagnosed with HIV-associated large B-cell lymphoma.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To establish the feasibility and safety of the regimen glofitamab plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (Glofit-RCHOP) in people with newly diagnosed Human Immunodeficiency Virus (HIV)-associated large B-cell lymphoma (LBCL).

SECONDARY OBJECTIVES:

  1. To evaluate the toxicity of Glofit-RCHOP when utilized in combination with antiretroviral therapy (ART) as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

II. To evaluate the overall response rate (ORR) and complete response rate (CRR) for Glofit-RCHOP in newly diagnosed HIV-associated LBCL using Lugano criteria.

III. To evaluate progression-free survival (PFS), duration of response (DoR), and overall survival (OS) for Glofit-RCHOP in newly diagnosed HIV-associated LBCL.

EXPLORATORY OBJECTIVES:

  1. To prospectively assess if circulating tumor deoxyribonucleic acid (ctDNA) levels at baseline and ctDNA dynamics (e.g., changes in ctDNA levels after 3 cycles and at end of treatment) can predict outcomes of therapy (PFS and OS).

II. To characterize the genetic subtypes of newly diagnosed HIV-associated LBCL based on commonly occurring genetic alterations.

III. To assess dynamic changes in cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) counts during treatment with Glofit-RCHOP.

IV. To assess the relationship between T-cell subsets, serum levels of cytokines, and inflammation-associated/microbial-translocation molecular profiles with clinical response in HIV-associated aggressive B-cell lymphomas treated with Glofit-RCHOP.

  1. To assess the impact of Glofit-RCHOP on quality of life (QoL). VI. To assess the prognostic significance of myelocytomatosis oncogene (MYC) overexpression (defined as MYC immunohistochemistry [IHC] ≥ 40%).

VII. To assess the association of HIV viral load prior to starting glofitamab on frequency and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

OUTLINE:

Patients receive RCHOP consisting of: rituximab intravenously (IV) over 90-360 minutes, cyclophosphamide IV over 1 hour, doxorubicin IV over 3-10 minutes, and vincristine IV over 3-10 minutes on day 1 of each cycle, and prednisone orally (PO) once daily (QD) on days 1-5 of each cycle. Patients also receive glofitamab IV over 4 hours on days 8 and 15 of cycle 2 and on day 8 of cycles thereafter. Cycles of RCHOP repeat every 21 days for 6 cycles, and cycles of glofitamab repeat every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiogram (ECHO), bone marrow biopsy or aspiration, positron emission tomography/computed tomography (PET/CT), and blood sample collection throughout the study. Patients may also undergo tumor tissue biopsy during screening.

After completion of study treatment, patients are followed every 3 months.

Being tested
Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Plasmablastic Lymphoma, Lymphoma, Primary Effusion

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 tumor tissue biopsy

  • Biospecimen CollectionProcedure or surgery

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

    Undergo blood sample collection

  • Bone Marrow AspirationProcedure or surgery

    Undergo bone marrow biopsy or aspiration

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow

    Undergo bone marrow biopsy or aspiration

  • Computed TomographyProcedure or surgery

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

    Undergo PET/CT

  • 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

  • Doxorubicin HydrochlorideDrug

    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 ECHO

  • GlofitamabBiological

    Also called Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody RO7082859, Columvi, Glofitamab-gxbm, RO 7082859

    Given IV

  • Positron Emission TomographyProcedure or surgery

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

    Undergo PET/CT

  • PrednisoneDrug

    Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

  • RituximabBiological

    Also called ABP 798, ABP-798, ABP798, BI 695500

    Given IV

  • Vincristine SulfateDrug

    Also called Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin

    Given IV

Study groups in NCT07649304
Study groupRoleWhat they receive
Treatment (RCHOP, glofitamab)ExperimentalPatients receive RCHOP consisting of: rituximab IV over 90-360 minutes, cyclophosphamide IV over 1 hour, doxorubicin IV over 3-10 minutes, and vincristine IV over 3-10 minutes on day 1 of each cycle, and prednisone PO QD on days 1-5 of each cycle. Patients also receive glofitamab IV over 2-8 hours on days 8 and 15 of cycle 2 and on day 8 of cycles thereafter. Cycles of RCHOP repeat every 21 days for 6 cycles, and cycles of glofitamab repeat every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO, bone marrow biopsy or aspiration, PET/CT, and blood sample collection throughout the study. Patients may also undergo tumor tissue biopsy during screening.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride; Procedure: Echocardiography Test; Biological: Glofitamab; Procedure: Positron Emission Tomography; Drug: Prednisone; Other: Questionnaire Administration; Biological: Rituximab; Drug: Vincristine Sulfate

What is being measured

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

  1. Ability to deliver at least 4 full cycles of glofitamab-rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (Glofit-RCHOP) (Feasibility)

    Feasibility status is defined by the ability to deliver at least 4 cycles of Glofit-RCHOP (i.e. study cycles 1-4). The proportion of the participants who completed at least 4 cycles of Glofit-RCHOP treatment (i.e. cycles 1-4) will be estimated. Will report 95% confidence interval of the above proportion. For the regimen Glofit-RCHOP to be declared feasible, at least 12 out of 15 evaluable participants must complete at least 4 full cycles of Glofit-RCHOP.

    Measured: Up to cycle 4 (Cycles = 21 days)

Secondary outcomes (6)

  1. Incidence and severity of adverse events (AEs) and serious AEs

    Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome will be graded using the American Society for Transplantation and Cellular Therapy Cytokine Release Syndrome criteria. All reported toxicities, regardless of attribution, by toxicity type and maximum grade will be summarized, and sorted by number of participants experiencing the toxicity. Safety data will be based mainly on the frequency and attribution of AEs, the frequency of discontinuation of treatment due to toxicity during study treatment, and the proportion of participants experiencing grade 3 or higher AEs related to the treatment components. AEs will be summarized by presenting the number and percentage of participants having any AE.

    Measured: Up to 2 years after completion of study treatment

  2. Complete response rates (CRR)

    Defined as the proportion of participants who achieve complete response (CR) among evaluable participants until end of treatment. CRR will be estimated using proportion and corresponding 95% confidence intervals using the Clopper-Pearson method.

    Measured: Up to 8 cycles (Cycles = 21 days)

  3. Overall response rate (ORR)

    Defined as the proportion of participants who achieve CR or partial response among evaluable participants. ORR will be estimated using proportion and corresponding 95% confidence intervals using the Clopper-Pearson method.

    Measured: Up to 8 cycles (Cycles = 21 days)

  4. Progression-free survival (PFS)

    Point estimates (e.g. median and 12 months PFS) with 95% confidence intervals will be calculated using the Kaplan-Meier product limit method to summarize the results. Differences in PFS by groups will be tested using the log-rank test. The association between baseline covariates and PFS will be assessed using a Cox proportional hazards regression model.

    Measured: From treatment initiation and date of documented progression or date of death from any cause, assessed up to 2 years after completion of study treatment

  5. Overall survival (OS)

    Point estimates (e.g. median and 12 months OS) with 95% confidence intervals will be calculated using the Kaplan-Meier product limit method to summarize the results. Differences in OS by groups will be tested using the log-rank test. The association between baseline covariates and OS will be assessed using a Cox proportional hazards regression model.

    Measured: From treatment initiation and date of death from any cause, assessed up to 2 years after completion of study treatment

  6. Duration of response (DoR)

    For DoR, responders who do not exhibit any disease progression or death during the follow-up will be censored at the last day of follow-up.

    Measured: From the date of first documented response and disease progression or death from any cause, assessed up to 2 years after completion of study treatment

Timeline

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

  1. First posted16 Jun 2026
  2. Study start5 Jul 2027 (estimated)
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Dec 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07649304
Sponsor's protocol ID
NCI-2026-04195
Other IDs
NCI-2026-04195, AMC-120, AMC-120, UM1CA121947
Status last verified
Nov 2026
First submitted
13 Jun 2026
Last updated
5 Nov 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 1 study testing Biopsy Procedure, Biospecimen Collection and Bone Marrow Aspiration in people with AIDS-Related Diffuse Large B-cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, run by National Cancer Institute (NCI) at 1 site 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 27 inclusion and 33 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Ability to deliver at least 4 full cycles of glofitamab-rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (Glofit-RCHOP) (Feasibility) (time frame: Up to cycle 4 (Cycles = 21 days)). 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 NCT07649304.

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 5 Nov 2026.

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