CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
GM-CSF (Sargramostim) +1 moredrug
Likely dose
GM-CSF (Sargramostim) 250 mcgfrom 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/NCT00940342
NCT00940342Phase 2Completed
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Rituximab In Combination With Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia (CLL)

M.D. Anderson Cancer Center·interventional·Posted Jul 16, 2009·Updated Sep 19, 2018

In Brief

A Phase 2 clinical trial evaluating GM-CSF (Sargramostim) and Rituximab for Leukemia. Completed, enrolled 130 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if giving granulocyte-macrophage colony-stimulating factor (GM-CSF) together with rituximab can improve the ability of rituximab to shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). The safety of this combination treatment will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 16, 2009
Enrollment StartOct 12, 2004
Primary CompletionJan 5, 2017
TodayJul 2, 2026
Enrollment to primary: 12.2 yearsPosted 17.0 years ago

Interventions

GM-CSF (Sargramostim)drug

250 mcg injection under the skin, three times a week for eight weeks.

Rituximabdrug

375 mg/m\^2 administered intravenously once weekly for four weeks