Slow accrual.
A Phase I Study of DT388GMCSF Fusion Protein in Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML)
Sponsor study identifier
interventional
7
1 country
1
Study Start
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2004
Actual (reported)Study Completion
December 2004
Actual (reported)DTGM belongs to a new generation of drugs designed to target leukemic cells. To achieve this, DTGM takes advantage of the ability of naturally-produced growth factor (GM, granulocyte-macrophage stimulating factor) to deliver a drug (diphtheria toxin) to cells; preferably leukemic cells. It then attaches to the cells and allows the toxin to enter the leukemic cells and destroy them.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2004
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
December 19, 2003
Actual (reported)December 23, 2003
Actual (reported)December 2004
Actual (reported)December 2004
Actual (reported)Starting dose of DTGM fusion protein 2 mcg/kg/day as a short (30 min) intravenous infusion, three times /week (M,W,F) for two consecutive weeks. In absence of defined grade 3/4 nonhematological toxicities in the first 0/3 or 1/6 patients, the dose will be escalated by 1 mcg/kg/day for the next patient cohort.
Starting dose: 2 mcg/kg by vein three times a week (M,W,F) for two consecutive weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Miloslav Beran, MD, PhD, DVM
M.D. Anderson Cancer Center
7 participants (actual enrollment reported by the registry).
First Submitted
December 19, 2003
First Posted
December 23, 2003
Study Start
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2004
Actual (reported)Study Completion
December 2004
Actual (reported)Last Updated
February 22, 2012
Record last verified: 2012-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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