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 : April 12, 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 ]
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) firstname.lastname@example.org|
|Contact: Mark J Roschewski, 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:||Mark J Roschewski, M.D.||National Cancer Institute (NCI)|