We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00006436
Recruitment Status : Recruiting
First Posted : November 6, 2000
Last Update Posted : January 2, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


  • 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.

Condition or disease Intervention/treatment Phase
Lymphoma, AIDS-related Lymphoma, Large B-Cell, Diffuse Biological: Rituximab Biological: filgrastim Drug: EPOCH Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short-Course EPOCH-Rituximab in Untreated CD-20+ HIV-Associated Lymphomas
Study Start Date : November 1, 2000
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Combo chemo and biological therapy
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
combination chemotheray: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles

Primary Outcome Measures :
  1. Progression-free survival at 1 year after completion of study treatment [ Time Frame: Time of progressive disease ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006436

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, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Wyndham H Wilson, M.D. National Cancer Institute (NCI)

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006436     History of Changes
Obsolete Identifiers: NCT00020384
Other Study ID Numbers: 010030
First Posted: November 6, 2000    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: June 6, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):

Additional relevant MeSH terms:
Lymphoma, Large B-Cell, Diffuse
Lymphoma, AIDS-Related
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents