CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
GM-CSF +1 morebiological
Likely dose
GM-CSF 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/NCT00548847
NCT00548847Phase 2Completed
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A Pilot Phase II Study of Immunotherapy for the Treatment of AML, ALL, BP CML, and MDS Relapsed After Allogeneic Transplantation

Emory University·interventional·Posted Oct 24, 2007·Updated Oct 26, 2016

In Brief

A Phase 2 clinical trial evaluating GM-CSF and Interferon-α-2b for Leukemia. Completed, enrolled 15 participants across 1 site.

Detailed Summary

The relapse of acute leukemia, MDS and blast phase CML after allogeneic transplantation affects approximately 1/3 to 1/2 of all transplant recipients and is the main cause of treatment failure. There is currently no effective standard treatment for this condition. This study will test the activity and feasibility of using a regimen to boost the immune system in order to treat AML, ALL, blast phase CML, and MDS relapse after allogeneic transplantation.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 24, 2007
Enrollment StartJan 1, 2007
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 18.7 years ago

Interventions

GM-CSFbiological

Dosing schedule: 250 mcg/m² subcutaneously Mon-Wed-Fri. Response assessed between 2 and 4 weeks. Duration on study is 3 months.

Interferon-α-2bbiological

Dosing schedule: 1.5 mcg/kg subcutaneously Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.