CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
Rituximab +2 morebiological
Likely dose
Rituximab 2 doses per cycle (Day 1 and Day 5); EPOCH chemotherapy every 3 weeks for 3-6 cycles; Filgrastim from Day 6 until ANC reaches 5000AI-extracted
Key inclusion· 5
  • CD20+ diffuse large B-cell lymphoma confirmed by pathology; plasmablastic lymphoma also eligible even if CD20 negative
  • Confirmed HIV seropositivity
  • All disease stages (I-IV) eligible
  • No prior cytotoxic chemotherapy, with limited exceptions (single prior cyclophosphamide for emergencies or single intrathecal MTX at diagnosis)
Key exclusion· 5
  • Prior rituximab therapy
  • Pregnancy or nursing (EPOCH-R drugs are teratogenic and excreted in milk)
  • Current clinical heart failure or symptomatic ischemic heart disease
  • Primary CNS lymphoma

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00006436
NCT00006436Phase 2Completed

Short-Course EPOCH - Rituximab in Untreated CD-20+ HIV-Associated Lymphomas

National Cancer Institute (NCI)·interventional·Posted Nov 6, 2000·Updated Dec 30, 2025

In Brief

A Phase 2 clinical trial evaluating Rituximab, Filgrastim, and 1 other intervention for Lymphoma, AIDS-related and Lymphoma, Large B-Cell, Diffuse. Completed, enrolled 68 participants across 1 site.

Detailed Summary

Background: * 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2000
Enrollment StartJan 29, 2001
Primary CompletionNov 30, 2020
Study CompletionJan 18, 2024
TodayJul 2, 2026
Enrollment to primary: 19.8 yearsPosted 25.7 years ago

Interventions

Rituximabbiological

2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5

Filgrastimbiological

Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle

EPOCHdrug

combination chemotheray: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles