CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 106 enrolled
Drug / intervention
rituximab +6 morebiological
Likely dose
EPOCH regimen (etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone) with rituximab IV; specific doses not stated in trial descriptionAI-extracted
Key inclusion· 8
  • Histologically or cytologically documented B-cell NHL (diffuse large cell, immunoblastic, anaplastic large cell, Burkitt's, or high-grade B-cell/Burkitt-like small non-cleaved)
  • CD20 positive tumors
  • Documented HIV infection by serology, culture, or quantitative PCR/bDNA assays
  • Evaluable or measurable disease
Key exclusion· 5
  • Prior chemotherapy or radiotherapy for this lymphoma
  • Primary CNS lymphoma (parenchymal brain or spinal cord tumor)
  • Acute active HIV-associated opportunistic infection requiring antibiotic treatment (mycobacterium avium allowed; chronic myelosuppressive therapy allowed if hematologic criteria met)
  • Concurrent malignancy excluding in situ cervical cancer, non-metastatic non-melanomatous skin cancer, or Kaposi's sarcoma not requiring systemic chemotherapy

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

Search/NCT00049036
NCT00049036Phase 2Completed

A Randomized Phase II Trial of EPOCH Given Either Concurrently or Sequentially With Rituximab in Patients With Intermediate- or High-Grade HIV-Associated B-cell Non-Hodgkin's Lymphoma

National Cancer Institute (NCI)·interventional·Posted Jan 27, 2003·Updated May 14, 2014

In Brief

A Phase 2 clinical trial evaluating rituximab, etoposide, and 5 other interventions for AIDS-related Diffuse Large Cell Lymphoma and 3 related conditions. Completed, enrolled 106 participants across 1 site.

Detailed Summary

This randomized phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with HIV-associated stage I, stage II, stage III, or stage IV non-Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.

Study Details

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

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMar 1, 2003
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 23.4 years ago

Interventions

rituximabbiological

Given IV

etoposidedrug

Given IV

doxorubicin hydrochloridedrug

Given IV

vincristine sulfatedrug

Given IV

prednisonedrug

Given orally

cyclophosphamidedrug

Given IV

laboratory biomarker analysisother

Correlative studies