CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
filgrastim +9 morebiological
Likely dose
rituximab 375 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00389818
NCT00389818Phase 2Completed

A Phase II Trial of Doxil, Rituximab, Cyclophosphamide, Vincristine, and Prednisone (DR-COP) in Patients With Newly Diagnosed AIDS-Associated B-Cell Non-Hodgkin's Lymphoma

AIDS Malignancy Consortium·interventional·Posted Oct 19, 2006·Updated Jun 6, 2018

In Brief

A Phase 2 clinical trial evaluating filgrastim, pegfilgrastim, and 8 other interventions for Lymphoma. Completed, enrolled 43 participants across 14 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving combination chemotherapy together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed AIDS-related B-cell non-Hodgkin's lymphoma.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 19, 2006
Enrollment StartJan 1, 2007
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 19.7 years ago

Interventions

filgrastimbiological

Supportive therapy: GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.

pegfilgrastimbiological

GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.

rituximabbiological

375 mg/m2 IV Day 1 of each cycle

sargramostimbiological

GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.

cyclophosphamidedrug

750 mg/m2 IV Day 1 of each cycle

pegylated liposomal doxorubicin hydrochloridedrug

40 mg/m2 IV Day 1 of each cycle

prednisonedrug

100 mg PO Days 1-5 of each cycle

vincristine sulfatedrug

1.4 mg/m2 IV Day 1 (2.0 mg maximum) of each cycle

immunohistochemistry staining methodother

tissue specimen collected at baseline

laboratory biomarker analysisother

tissue specimen collected at baseline