CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
sargramostim +6 morebiological
Likely dose
Not stated in 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/NCT00425477
NCT00425477Phase 2Completed

A Phase II Study of Bexarotene + Sargromastastin as Agents of Differentiation in MDS and AML

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Jan 23, 2007·Updated Oct 5, 2018

In Brief

A Phase 2 clinical trial evaluating sargramostim, bexarotene, and 5 other interventions for Leukemia and 2 related conditions. Completed, enrolled 26 participants across 1 site.

Detailed Summary

RATIONALE: Bexarotene may help cancer or abnormal cells become more like normal cells, and to grow and spread more slowly. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving bexarotene together with GM-CSF may be an effective treatment for myelodysplastic syndrome (MDS) or acute myeloid leukemia. PURPOSE: This phase II trial is studying how well giving bexarotene together with GM-CSF works in treating patients with MDS or acute myeloid leukemia.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 23, 2007
Enrollment StartNov 1, 2006
Primary CompletionSep 30, 2016
TodayJul 2, 2026
Enrollment to primary: 9.9 yearsPosted 19.4 years ago

Interventions

sargramostimbiological

bexarotenedrug

cytogenetic analysisgenetic

fluorescence in situ hybridizationgenetic

flow cytometryother

laboratory biomarker analysisother

biopsyprocedure