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EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection

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ClinicalTrials.gov Identifier: NCT00006436
Recruitment Status : Recruiting
First Posted : November 6, 2000
Last Update Posted : January 1, 2018
Information provided by (Responsible Party):

November 3, 2000
November 6, 2000
January 1, 2018
November 1, 2000
March 31, 2019   (Final data collection date for primary outcome measure)
Progression-free survival at 1 year after completion of study treatment [ Time Frame: Time of progressive disease ]
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Complete list of historical versions of study NCT00006436 on ClinicalTrials.gov Archive Site
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EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection
Short-Course EPOCH-Rituximab in Untreated CD-20+ HIV-Associated Lymphomas


  • 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.


  • 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.


-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.


  • Patients receive EPOCH-R in 3-week treatment cycles for at least three and no more than six cycles.
  • The lymphoma is evaluated using CT and 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.


This is a study to investigate in a preliminary fashion the feasibility of short course chemotherapy to patients 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.


To assess with 90 percent probability that at least 50 percent of patients treated with short-course EPOCH-R will be progression free at one year.


Aggressive CD20 positive DLBCL.

HIV+ serology.

All stages (I-IV) of disease.

ECOG Performance status 0-4.

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.


Patients will be treated every three weeks with a combination of EPOCH and rituximab for one cycle beyond CR/CRu by 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 patients 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.

Anti-HIV therapy will be suspended prior to initiation of the chemotherapy and optimum therapy will be reinitiated after all the cycles have been administered.

To study the effects of treatment approach on parameters of HIV disease, measurements of 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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Lymphoma, AIDS-related
  • Lymphoma, Large B-Cell, Diffuse
  • Biological: Rituximab
    2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5
  • Biological: filgrastim
    Figrastim day 6 until ANC reaches 5000 after the nadir, every cycle
  • Drug: EPOCH
    combination chemotheray: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
Experimental: 1
Combo chemo and biological therapy
  • Biological: Rituximab
  • Biological: filgrastim
  • Drug: EPOCH

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 31, 2021
March 31, 2019   (Final data collection date for primary outcome measure)

Aggressive CD20 positive Diffuse Large B-cell lymphoma confirmed by Laboratory of Pathology, NCI.

HIV + serology.

All stages (I-IV) of disease.

ECOG Performance status 0-4

NHL previously untreated with cytotoxic chemotherapy; however, patients 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 methotrexte (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 patients for whom these abnormalities are felt to be due to protease inhibitor therapy
  • AST and ALT less than or equal to 3x ULN (AST and ALT less than or equal to 6x ULN for patients on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation)
  • ANC greater than or equal to 1000/mm(3)
  • Platelet greater than or equal to 75,000/mm(3) (unless impairment due to ITP)

Ability of patient to provide informed consent.


Previous rituximab

Pregnancy or nursing.

  • Doxorubicin, etoposide, vincristine and cyclophosphamide are teratogenic and may be excreted in milk.
  • Antiretroviral therapy is indicated during pregnancy and nursing.

Current clinical heart failure or symptomatic ischemic heart disease.

Serious underlying medical condition or infection other than HIV that would contraindicate SC-EPOCH-R.

  • Examples include, but are not limited to:
  • Severe AIDS-related wasting
  • Sever intractable diarrhea
  • Active inadequately treated opportunistic infection of the CNS

Concurrent anti-retroviral therapy during EPOCH therapy.

Primary CNS lymphoma.

Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
Contact: Margaret Shovlin, R.N. (240) 760-6089 mshovlin@mail.nih.gov
Contact: Wyndham H Wilson, M.D. (240) 760-6092 wilsonw@mail.nih.gov
United States
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National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
National Cancer Institute (NCI)
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Principal Investigator: Wyndham H Wilson, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
June 6, 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP