EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection
NCT ID: NCT00006436
Last Updated: 2025-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
68 participants
INTERVENTIONAL
2001-01-29
2024-01-18
Brief Summary
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* Human immunodeficiency virus (HIV)-infected patients have a weakened immune system, and chemotherapy, which is used to treat lymphoma, probably causes further damage to the immune system.
* Limiting the amount of immune damage due to chemotherapy might decrease the number of infections and the risk of developing cancer in the future in HIV-infected patients with non-Hodgkin's lymphoma.
Objectives:
* To determine whether reducing the total amount of chemotherapy using a specific combination of drugs called EPOCH-R (etoposide, doxorubicin, vincristine, cyclophosphamide and rituximab) will rid the body of lymphoma quickly while decreasing the risk of infections and future cancers.
* To determine whether the lymphoma will remain undetectable for at least one year if treatment is stopped one cycle after the patient enters remission.
Eligibility:
-Patients with non-Hodgkin's lymphoma and HIV infection 4 years of age and older who have not been treated previously with rituximab or cytotoxic chemotherapy.
Design:
* Patients receive EPOCH-R in 3-week treatment cycles for at least three and no more than six cycles.
* The lymphoma is evaluated using computed tomography (CT) and positron emission tomography (PET) scans at the end of treatment cycles 2 and 3. A bone marrow biopsy is repeated after cycle 2 if a biopsy was initially positive on screening for participation in the study.
* Anti-HIV therapy is stopped before chemotherapy begins and is restarted when EPOCH-R treatment ends.
* Patients are monitored for treatment response with blood tests and imaging scans at baseline, when treatment ends, 2 months after treatment ends and then every 3 to 6 months for a total of 24 months following chemotherapy.
Detailed Description
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This is a study to investigate in a preliminary fashion the feasibility of short course chemotherapy to participants with HIV-associated non-Hodgkin's lymphoma (HIV-NHL).
This study will investigate if the paradigm for treatment can be successfully changed from a standard of 6 cycles to one cycle beyond complete remission with 6 total allowable cycles.
Objective:
To assess with 90 percent probability that at least 50 percent of participants treated with short-course EPOCH-R (etoposide, doxorubicin, vincristine, cyclophosphamide and rituximab) will be progression free at one year.
Eligibility:
Aggressive B-lymphocyte antigen CD20 (CD20) positive Diffuse large B cell lymphoma (DLBCL).
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.
Age greater than or equal to 18 years.
May not be pregnant or nursing.
May not have received previous rituximab.
Design:
Participants will be treated every three weeks with a combination of EPOCH and rituximab for one cycle beyond complete remission (CR)/complete response unconfirmed (CRu) by computed tomography (CT) scan of all detectable tumors for a minimum of three and maximum of six cycles. Following cycle 2, CT, positron emission tomography scans (PET), and bone marrow biopsies (if initially positive) will be performed.
At the conclusion of the study, we will estimate whether the number of cycles can be reduced using the paradigm. If the cumulative number of participants to relapse exceeds 25 percent by 6 months, the study will be closed.
Following the completion of chemotherapy, restaging will be performed 2 months following the end of treatment, then every 3 months for one year, every 6 months for one year, then every 12 months until relapse, death, or loss to follow up.
Antiretroviral therapy (ART) will be given concurrently with treatment regimen.
To study the effects of treatment approach on parameters of HIV disease, measurements of cluster of differentiation 4 (CD4) cells and viral loads will be made at baseline and at the completion of therapy, and then 2 months following the end of treatment, and then every 3-6 months for a total of 24 months following chemotherapy.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1-Combination Chemo and Biological Therapy
Combination chemo and biological therapy
Rituximab
2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim
Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
EPOCH
combination chemotheray: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
Interventions
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Rituximab
2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
Filgrastim
Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle
EPOCH
combination chemotheray: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Max Gordon
Principal Investigator
Principal Investigators
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Max Gordon, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Countries
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References
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Kurtz DM, Scherer F, Jin MC, Soo J, Craig AFM, Esfahani MS, Chabon JJ, Stehr H, Liu CL, Tibshirani R, Maeda LS, Gupta NK, Khodadoust MS, Advani RH, Levy R, Newman AM, Duhrsen U, Huttmann A, Meignan M, Casasnovas RO, Westin JR, Roschewski M, Wilson WH, Gaidano G, Rossi D, Diehn M, Alizadeh AA. Circulating Tumor DNA Measurements As Early Outcome Predictors in Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2018 Oct 1;36(28):2845-2853. doi: 10.1200/JCO.2018.78.5246. Epub 2018 Aug 20.
Dunleavy K, Pittaluga S, Shovlin M, Steinberg SM, Cole D, Grant C, Widemann B, Staudt LM, Jaffe ES, Little RF, Wilson WH. Low-intensity therapy in adults with Burkitt's lymphoma. N Engl J Med. 2013 Nov 14;369(20):1915-25. doi: 10.1056/NEJMoa1308392.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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01-C-0030
Identifier Type: -
Identifier Source: secondary_id
010030
Identifier Type: -
Identifier Source: org_study_id
NCT00020384
Identifier Type: -
Identifier Source: nct_alias