CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Rituximab +1 morebiological
Likely dose
Rituximab 375 mgfrom 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/NCT00411086
NCT00411086Phase 2Completed

Single-Arm, Open-Label, Phase II Trial of Rituximab Plus Sargramostim for the Treatment of Newly Diagnosed Follicular B-Cell Lymphoma in Adults

M.D. Anderson Cancer Center·interventional·Posted Dec 13, 2006·Updated Dec 5, 2017

In Brief

A Phase 2 clinical trial evaluating Rituximab and Sargramostim (GM-CSF) for Lymphoma. Completed, enrolled 60 participants across 1 site.

Detailed Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with GM-CSF may be an effective treatment for follicular B-cell lymphoma. PURPOSE: This phase II trial is studying the side effects and how well giving rituximab together with GM-CSF works in treating patients with newly diagnosed follicular B-cell lymphoma.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 13, 2006
Enrollment StartNov 1, 2006
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 yearsPosted 19.6 years ago

Interventions

Rituximabbiological

375 mg/m\^2 By Vein Weekly on Days 1, 8, 15, and 22.

Sargramostim (GM-CSF)biological

250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.