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 2, 2018
- 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)|
|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|
Combo chemo and biological therapy
2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5Biological: filgrastim
Figrastim day 6 until ANC reaches 5000 after the nadir, every cycleDrug: EPOCH
combination chemotheray: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
- Progression-free survival at 1 year after completion of study treatment [ Time Frame: Time of progressive disease ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006436
|Contact: Margaret Shovlin, R.N.||(240) firstname.lastname@example.org|
|Contact: Wyndham H Wilson, M.D.||(240) email@example.com|
|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|
|Principal Investigator:||Wyndham H Wilson, M.D.||National Cancer Institute (NCI)|