Shorter chemo shows promise for HIV patients with lymphoma
NCT ID NCT00006436
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This study tested a shorter course of a chemotherapy combination called EPOCH-R in 68 people with HIV and a type of lymphoma. The goal was to see if reducing the amount of chemotherapy could still control the cancer while causing less damage to the immune system. Participants received treatment every 3 weeks for 3 to 6 cycles, and their response was monitored with scans and blood tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab)
- What this could lead to
- If successful, this approach could offer a shorter, less immune-damaging chemotherapy regimen for people with HIV and lymphoma, potentially reducing infections and future cancer risks.
- What could go wrong
- This is a small, completed phase 2 trial with no control group, so results are preliminary. The combination still carries significant toxicity risks, and long-term outcomes are uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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68 people
The number who actually took part.
- Started
-
Jan 2001
- Finished
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Jan 2024
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Aggressive B-lymphocyte antigen CD20 (CD20) positive Diffuse Large B-cell lymphoma confirmed by Laboratory of Pathology, National Cancer Institute (NCI). Note: Participants with aggressive B-cell lymphoma of the plasmablastic lymphoma sub-type who do not have surface CD20 expression, are also eligible. Human immunodeficiency virus (HIV) + serology. All stages (I-IV) of disease. Eastern Cooperative Oncology Group (ECOG) Performance status 0-4 Non-Hodgkin's Lymphoma (NHL) previously untreated with cytotoxic chemotherapy; however, participants may be entered if they have had prior cyclophosphamide for an urgent problem at diagnosis (e.g., epidural cord compression, superior vena cava syndrome) and/or a single dose of intrathecal methotrexate (MTX) at the time of the pre-treatment diagnostic lumbar puncture Age greater than or equal to 18 years Laboratory tests (unless impairment due to respective organ involvement by tumor): * Creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than or equal to 50 ml/min * Bilirubin less than 2.0 mg/dl, or total bilirubin less than or equal to 4.5 mg/dl with direct fraction less than or equal to 0.3 mg/dl in participants for whom these abnormalities are felt to be due to protease inhibitor therapy * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3x upper limit of normal (ULN) (AST and ALT less than or equal to 6x ULN for participants on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation) * Absolute neutrophil count (ANC) greater than or equal to 1000/mm(3) * Platelet greater than or equal to 75,000/mm(3) (unless impairment due to Immune thrombocytopenic purpura (ITP) Ability of participant to provide informed consent. EXCLUSION CRITERIA: Previous rituximab Pregnancy or nursing. \- Doxorubicin, etoposide, vincristine and cyclophosphamide are teratogenic and may be excreted in milk. Current clinical heart failure or symptomatic ischemic heart disease. Serious underlying medical condition or infection other than HIV that would contraindicate subcutaneous (SC)-rituximab, etoposide phosphate, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (hydroxydaunorubicin (EPOCH-R). * Examples include, but are not limited to: * Severe Acquired immunodeficiency syndrome (AIDS)-related wasting * Sever intractable diarrhea * Active inadequately treated opportunistic infection of the central nervous system (CNS) * Primary CNS lymphoma Primary CNS lymphoma
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
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Other studies related to the condition(s) this trial covers.
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