Diffuse Large Cell LymphomaPhase 1NCT05389423
Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas
A Phase 1 study testing Vincristine, Prednisone and Doxorubicin in people with Diffuse Large Cell Lymphoma and Non-Hodgkin Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Non-Hodgkin lymphoma (NHL) is the most common cancer among people living with HIV in the United States. People with HIV are up to 17 times more likely to get NHL than people who do not have HIV. The disease may also be different in these two groups. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Diffuse Large Cell Lymphoma, Non-Hodgkin Lymphoma, Burkitt Lymphoma
- What is being tested?
- Vincristine, Prednisone and Doxorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2023to 1 Jun 2032
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed B-cell NHL confirmed by the Laboratory of Pathology (LP), NCI, with one or more of the following features:
- Leptomeningeal/CSF involvement
- High-risk for CNS relapse per CNS-IPI (score 4-6)
- Plasmablastic histology
- Gamma herpesvirus positive tumor
- Presence of KS
Show all 24Show fewer
- Measurable or evaluable lymphoma.
- Positive HIV1/2 serology.
- Individuals may not have received prior curative-intent chemotherapy for lymphoma. Individuals who have received prior treatment as a bridge to curative-intent therapy will be considered per Protocol Chair discretion if >= 2 weeks since administration. Steroids given for any reason or rituximab given for multicentric Castleman disease may be given any time prior to treatment start.
- Age >=18 years
- Eastern Cooperative Oncology Group performance status (ECOG-PS) <=4
- Individuals of childbearing potential (IOCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 2 weeks prior to and again within 1 day before starting the study drugs and must either commit to continued abstinence from penetrative vaginal intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before the participant starts taking pomalidomide and for 12 months after the last dose of combined chemotherapy.
- Individuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to six (6) months after the last dose of the study drug(s). We also will recommend individuals able to father a child with IOCBP partners to ask the partners to be on an effective birth control (hormonal, intrauterine device (IUD), surgical sterilization). Individuals able to father a child must not freeze or donate sperm within the same period.
- All individuals must agree to be registered into the mandatory POMALYST REMS(R)TM program and be willing and able to comply with the requirements of the POMALYST REMS(R)TM program.
- Able to take aspirin 81mg orally daily or another substitute thromboprophylaxis.
- Adequate organ and marrow function as defined below unless abnormalities are attributed to lymphoma or HIV as determined by investigator:
- absolute neutrophil count >=1,000/mcL
- platelets >=75,000/mcL
- total bilirubin <=1.5 X institutional upper limit of normal (individuals with history of Gilbert disease are eligible if total bilirubin <= 5 mg/dL with <80% unconjugated bilirubin)
- aspartate aminotransferase (AST) / alanine transaminase (ALT) <=3 X institutional upper limit of normal
- creatinine clearance >=60 mL/min/1.73 m^2 for individuals with creatinine levels above institutional normal.
- Hepatitis B virus (HBV) infection must be on suppressive antiviral therapy.
- Willingness to take and adhere to ART (individuals are not required to be on any specific regimen of ART).
- Individuals must understand and sign a written informed consent document.
Who cannot join
- Individuals may not receive investigational agents on other clinical trials.
- Requirement of any of the agents listed as prohibited thearapies.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide or other agents used in study.
- Parenchymal brain involvement with lymphoma.
- Ejection fraction less than 40% by echocardiography (ECHO)
- CTCAEv5.0 Grade 3-4 neuropathy
Show all 16Show fewer
- History of malignant tumors other than KS or KSHV-associated multicentric Castleman Disease, (MCD), unless:
- In complete remission for >= 1 year from the time response was first documented; or,
- Completely resected basal cell carcinoma; or,
- In situ squamous cell carcinoma of the cervix or anus; or,
- Prior or concurrent malignancy has a natural history or treatment which does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen per Protocol Chair discretion.
- Known drug-related, inherited, or acquired procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome.
- Symptomatic congestive heart failure
- Unstable angina pectoris, symptomatic cardiac arrhythmia, or cardiac arrhythmia requiring medical treatment.
- Uncontrolled intercurrent illness or participants considered to be of poor medical health due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection (excluding lymphoma or HIV) as documented in prior records or suggested by medical history, physical examination or standard clinical assessments such as imaging and laboratory studies.
- Pregnant or nursing individuals (if lactating, must agree not to nurse while taking pomalidomide).
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
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
Official title: Phase I Trial of Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas
Background:
Non-Hodgkin lymphoma (NHL) is the most common cancer among people living with HIV in the United States. People with HIV are up to 17 times more likely to get NHL than people who do not have HIV. The disease may also be different in these two groups. More study is needed for treating
Read more
people with both HIV and NHL.
Objective:
To test a study drug (pomalidomide) in combination with chemotherapy with or without another drug (rituximab) in people with HIV-associated NHL.
Eligibility:
Adults aged 18 years or older diagnosed with HIV-associated B-cell NHL with high-risk features.
Design:
Individuals will undergo screening. They will have a physical exam. They will have blood and urine tests and tests of heart function. They may have imaging scans. Researchers will review tissue samples of individual s tumors. In some cases, a new biopsy may be needed.
Individuals will receive up to 6 cycles of treatment.
The first cycle is 26 days: Individuals will take pomalidomide by mouth for 10 days. After 5 days they will start receiving chemotherapy drugs through a tube attached to a needle placed in a vein (IV). Some participants will receive rituximab on day 5. All individuals will receive a second set of IV drugs that will last for 4 days (96 hours). They will receive another IV drug after the previous treatment is complete.
The remaining cycles are each 21 days. Individuals will take pomalidomide by mouth for the first 10 days. Other chemotherapy treatments will also be repeated starting on day 1 of each cycle.
Screening tests will be repeated at study visits.
Follow-up visits will continue for 4 years....
Read the detailed description
Background:
- Non-Hodgkin lymphoma (NHL) is the most common cancer among people living with human immunodeficiency virus (HIV) (PLWH) in the United States. Even in the modern era of antiretroviral therapy (ART), PLWH have an 11- to 17-fold higher risk of NHL than the general population due in part to CD4+ T-cell lymphopenia but also immune dysregulation and exhaustion from chronic viral antigen stimulation.
- The most common NHL subtypes are diffuse large cell lymphoma (DLBCL) and Burkitt lymphoma (BL), that are much more frequently associated with the oncogenic virus Epstein Barr virus (EBV) in PLWH, which portends a poorer prognosis, than in the general population.
- Plasmablastic lymphoma (PBL) is a rare CD20 negative B cell lymphoma associated with EBV almost exclusively seen in PLWH.
- Although these subtypes of lymphoma occur in the general population, their presentation and pathogenesis may be different - meaning there may be different therapeutic targets and strategies to consider in HIV-associated lymphomas necessitating clinical trials targeted to this underserved population of patients.
- Lenalidomide, a 2nd generation immunomodulatory drug, has shown safety and improved survival in combination with chemotherapy in advanced stage DLBCL in one of two randomized trials.
- Pomalidomide, a 3rd generation immunomodulatory agent, has activity in primary central nervous system (CNS) lymphoma demonstrating its activity in both NHL and CNS involvement, which is more common in PLWH and NHL. In a number of parameters, it is more potent than lenalidomide.
- Pomalidomide has shown to increase natural killer (NK) and T-cell activation and reverse T-cell senescence in addition to increasing CD4+ T-cell count in PLWH and cancer. It can also enhance expression of surface immune markers in vitro in cell lines from EBV-induced tumors.
- Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) along with rituximab (DA-EPOCH-R) is an anthracycline-based regimen that has been shown to be safe and effective in PLWH and in the most common subtypes of NHL seen in PLWH, DLBCL and BL.
Objective:
-Determine the safety and maximum tolerated dose (MTD) of the combination of pomalidomide and dose-adjusted EPOCH +/ rituximab (DA-EPOCH-RP) in participants with enrolled subtypes of HIV-associated lymphomas
Eligibility:
- Adult participants >= 18 years with pathology-confirmed HIV-associated B-cell non-Hodgkin lymphoma with high-risk features, excluding primary CNS lymphoma
- Positive HIV1/2 serology
Design:
- This is a phase 1 study of DA-EPOCH-RP in participants with HIV-associated B-cell non-Hodgkin lymphoma. Only participants with CD20+ HIV-associated B-cell non-Hodgkin lymphoma will receive Rituximab.
- This is a dose escalation study to evaluate pomalidomide in combination with modified DA-EPOCH-R to determine safety and tolerability. Dosing will begin at dose level 1, 3 mg of pomalidomide and proceed to dose escalation or de-escalation to doses 4 mg or 2 mg depending on dose-limiting toxicities.
- Participants will be prescribed ART.
- In this phase I study, up to 12 evaluable participants will be accrued in the escalation phase (3-6 participants per level) and up to 6 evaluable participants will be accrued in the expansion phase to be treated at MTD.
- Conditions
- Diffuse Large Cell Lymphoma, Non-Hodgkin Lymphoma, Burkitt Lymphoma, Plasmablastic Lymphoma, B-Cell Neoplasm
- Being tested
- Vincristine, Prednisone, Doxorubicin, Etoposide, Pomalidomide
- Keywords
- Non-Hodgkin Lymphoma, Epstein Barr Virus, Plasmablastic Lymphoma, Chemotherapy, Immune Modulatory
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Burkitt Lymphoma, Plasmablastic Lymphoma, Lymphoma, B-Cell, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VincristineDrug
0.4 mg/m2/day administered by CIVI on days 1 to 4
PrednisoneDrug
60 mg/m2/day administered orally on days 1 to 5
DoxorubicinDrug
10 mg/m2/day administered by CIVI on days 1 to 4
EtoposideDrug
50 mg/m2/day administered by CIVI on days 1 to 4
PomalidomideDrug
An initial dose of 3mg administered orally for 10 days in all cycles. In cycle 1, it will start 5 days before DA-EPOCH; in cycles 2-6, it will start on day 1. Administered at an MTD dose for the expansion phase.
CyclophosphamideDrug
750 mg/m2 administered IV on day 5
RituximabDrug
375 mg/m2 administered IV on day 1 (only for CD20+ tumors)
| Study group | Role | What they receive |
|---|---|---|
| 1/Dose Escalation | Experimental | Pomalidomide (escalating doses) + Prednisone, Etoposide, Doxorubicin, Vincristin Receives: Drug: Vincristine; Drug: Prednisone; Drug: Doxorubicin; Drug: Etoposide; Drug: Pomalidomide; Drug: Cyclophosphamide; Drug: Rituximab |
| 2/Dose Expansion | Experimental | Pomalidomide (at the MTD) + Prednisone, Etoposide, Doxorubicin, Vincristine and Receives: Drug: Vincristine; Drug: Prednisone; Drug: Doxorubicin; Drug: Etoposide; Drug: Pomalidomide; Drug: Cyclophosphamide; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability
The fraction of individuals with toxicity noted at each dose level will be reported by grade and type of toxicity identified. Maximum tolerated dose will also be reported.
Measured: 6 cycles of treatment, or until confirmed progression, unacceptable toxicity or trial withdrawal
Secondary outcomes (2)
progression-free survival
duration of time from the start of the treatment until time of disease relapse from PR, disease progression, or death, whichever occurs first
Measured: every 3 weeks for the first 6 cycles, every 3 months for the rest of the first year, then every 6 months for 4 years (5 years total).
preliminary estimates of response
Percentage of individuals with the best overall response of CR or PR to therapy
Measured: every 3 weeks for the first 6 cycles, every 3 months for the rest of the first year, then every 6 months for 4 years (5 years total).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start27 Jun 2023
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large Cell LymphomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ramya M Ramaswami, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389423
- Sponsor's protocol ID
- 10000274
- Other IDs
- 000274-C
- Status last verified
- 21 Aug 2026
- First submitted
- 21 May 2022
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas
- ClinicalTrials.gov ID
- NCT05389423
- Acronym / sponsor ID
- 10000274
- Conditions
- Diffuse Large Cell Lymphoma, Non-Hodgkin Lymphoma, Burkitt Lymphoma, Plasmablastic Lymphoma, B-Cell Neoplasm
- Keywords
- Non-Hodgkin Lymphoma, Epstein Barr Virus, Plasmablastic Lymphoma, Chemotherapy, Immune Modulatory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2032 (estimated)
- First posted
- 25 May 2022 (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.
Background:
Non-Hodgkin lymphoma (NHL) is the most common cancer among people living with HIV in the United States. People with HIV are up to 17 times more likely to get NHL than people who do not have HIV. The disease may also be different in these two groups. More study is needed for treating
people with both HIV and NHL.
Objective:
To test a study drug (pomalidomide) in combination with chemotherapy with or without another drug (rituximab) in people with HIV-associated NHL.
Eligibility:
Adults aged 18 years or older diagnosed with HIV-associated B-cell NHL with high-risk features.
Design:
Individuals will undergo screening. They will have a physical exam. They will have blood and urine tests and tests of heart function. They may have imaging scans. Researchers will review tissue samples of individual s tumors. In some cases, a new biopsy may be needed.
Individuals will receive up to 6 cycles of treatment.
The first cycle is 26 days: Individuals will take pomalidomide by mouth for 10 days. After 5 days they will start receiving chemotherapy drugs through a tube attached to a needle placed in a vein (IV). Some participants will receive rituximab on day 5. All individuals will receive a second set of IV drugs that will last for 4 days (96 hours). They will receive another IV drug after the previous treatment is complete.
The remaining cycles are each 21 days. Individuals will take pomalidomide by mouth for the first 10 days. Other chemotherapy treatments will also be repeated starting on day 1 of each cycle.
Screening tests will be repeated at study visits.
Follow-up visits will continue for 4 years....
Detailed description
Background:
- Non-Hodgkin lymphoma (NHL) is the most common cancer among people living with human immunodeficiency virus (HIV) (PLWH) in the United States. Even in the modern era of antiretroviral therapy (ART), PLWH have an 11- to 17-fold higher risk of NHL than the general population due in part to CD4+ T-cell lymphopenia but also immune dysregulation and exhaustion from chronic viral antigen stimulation.
- The most common NHL subtypes are diffuse large cell lymphoma (DLBCL) and Burkitt lymphoma (BL), that are much more frequently associated with the oncogenic virus Epstein Barr virus (EBV) in PLWH, which portends a poorer prognosis, than in the general population.
- Plasmablastic lymphoma (PBL) is a rare CD20 negative B cell lymphoma associated with EBV almost exclusively seen in PLWH.
- Although these subtypes of lymphoma occur in the general population, their presentation and pathogenesis may be different - meaning there may be different therapeutic targets and strategies to consider in HIV-associated lymphomas necessitating clinical trials targeted to this underserved population of patients.
- Lenalidomide, a 2nd generation immunomodulatory drug, has shown safety and improved survival in combination with chemotherapy in advanced stage DLBCL in one of two randomized trials.
- Pomalidomide, a 3rd generation immunomodulatory agent, has activity in primary central nervous system (CNS) lymphoma demonstrating its activity in both NHL and CNS involvement, which is more common in PLWH and NHL. In a number of parameters, it is more potent than lenalidomide.
- Pomalidomide has shown to increase natural killer (NK) and T-cell activation and reverse T-cell senescence in addition to increasing CD4+ T-cell count in PLWH and cancer. It can also enhance expression of surface immune markers in vitro in cell lines from EBV-induced tumors.
- Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) along with rituximab (DA-EPOCH-R) is an anthracycline-based regimen that has been shown to be safe and effective in PLWH and in the most common subtypes of NHL seen in PLWH, DLBCL and BL.
Objective:
-Determine the safety and maximum tolerated dose (MTD) of the combination of pomalidomide and dose-adjusted EPOCH +/ rituximab (DA-EPOCH-RP) in participants with enrolled subtypes of HIV-associated lymphomas
Eligibility:
- Adult participants >= 18 years with pathology-confirmed HIV-associated B-cell non-Hodgkin lymphoma with high-risk features, excluding primary CNS lymphoma
- Positive HIV1/2 serology
Design:
- This is a phase 1 study of DA-EPOCH-RP in participants with HIV-associated B-cell non-Hodgkin lymphoma. Only participants with CD20+ HIV-associated B-cell non-Hodgkin lymphoma will receive Rituximab.
- This is a dose escalation study to evaluate pomalidomide in combination with modified DA-EPOCH-R to determine safety and tolerability. Dosing will begin at dose level 1, 3 mg of pomalidomide and proceed to dose escalation or de-escalation to doses 4 mg or 2 mg depending on dose-limiting toxicities.
- Participants will be prescribed ART.
- In this phase I study, up to 12 evaluable participants will be accrued in the escalation phase (3-6 participants per level) and up to 6 evaluable participants will be accrued in the expansion phase to be treated at MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/Dose Escalation | Experimental | Drug: Vincristine, Drug: Prednisone, Drug: Doxorubicin, Drug: Etoposide, Drug: Pomalidomide, Drug: Cyclophosphamide, Drug: RituximabPomalidomide (escalating doses) + Prednisone, Etoposide, Doxorubicin, Vincristin |
| 2/Dose Expansion | Experimental | Drug: Vincristine, Drug: Prednisone, Drug: Doxorubicin, Drug: Etoposide, Drug: Pomalidomide, Drug: Cyclophosphamide, Drug: RituximabPomalidomide (at the MTD) + Prednisone, Etoposide, Doxorubicin, Vincristine and |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Histologically or cytologically confirmed B-cell NHL confirmed by the Laboratory of Pathology (LP), NCI, with one or more of the following features:
- Measurable or evaluable lymphoma.
- Positive HIV1/2 serology.
- Individuals may not have received prior curative-intent chemotherapy for lymphoma. Individuals who have received prior treatment as a bridge to curative-intent therapy will be considered per Protocol Chair discretion if >= 2 weeks since administration. Steroids given for any reason or rituximab given for multicentric Castleman disease may be given any time prior to treatment start.
- Age >=18 years
Key exclusion criteria (16 listed)
- Individuals may not receive investigational agents on other clinical trials.
- Requirement of any of the agents listed as prohibited thearapies.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide or other agents used in study.
- Parenchymal brain involvement with lymphoma.
- Ejection fraction less than 40% by echocardiography (ECHO)
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 |
|---|---|---|
| Vincristine0.4 mg/m2/day administered by CIVI on days 1 to 4 | Drug | 1/Dose Escalation, 2/Dose Expansion |
| Prednisone60 mg/m2/day administered orally on days 1 to 5 | Drug | 1/Dose Escalation, 2/Dose Expansion |
| Doxorubicin10 mg/m2/day administered by CIVI on days 1 to 4 | Drug | 1/Dose Escalation, 2/Dose Expansion |
| Etoposide50 mg/m2/day administered by CIVI on days 1 to 4 | Drug | 1/Dose Escalation, 2/Dose Expansion |
| PomalidomideAn initial dose of 3mg administered orally for 10 days in all cycles. In cycle 1, it will start 5 days before DA-EPOCH; in cycles 2-6, it will start on day 1. Administered at an MTD dose for the expansion phase. | Drug | 1/Dose Escalation, 2/Dose Expansion |
| Cyclophosphamide750 mg/m2 administered IV on day 5 | Drug | 1/Dose Escalation, 2/Dose Expansion |
| Rituximab375 mg/m2 administered IV on day 1 (only for CD20+ tumors) | Drug | 1/Dose Escalation, 2/Dose Expansion |
Primary outcome
safety and tolerability
Time frame: 6 cycles of treatment, or until confirmed progression, unacceptable toxicity or trial withdrawal
The fraction of individuals with toxicity noted at each dose level will be reported by grade and type of toxicity identified. Maximum tolerated dose will also be reported.
2 secondary outcomes
progression-free survival
Time frame: every 3 weeks for the first 6 cycles, every 3 months for the rest of the first year, then every 6 months for 4 years (5 years total).
preliminary estimates of response
Time frame: every 3 weeks for the first 6 cycles, every 3 months for the rest of the first year, then every 6 months for 4 years (5 years total).
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 25 Aug 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
Related trials for Diffuse Large Cell Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
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.
Ramya M Ramaswami, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vincristine, Prednisone and Doxorubicin in people with Diffuse Large Cell Lymphoma and Non-Hodgkin Lymphoma, 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 24 inclusion and 16 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 25 Aug 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?
Contact Irene B Ekwede, R.N. ((240) 760-6126, ekwedeib@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability (time frame: 6 cycles of treatment, or until confirmed progression, unacceptable toxicity or trial withdrawal). 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 25 Aug 2026.