A Randomized Study of Once Daily IV Busulfan With Fludarabine With Hemopoietic Stem Cell Transplantation for Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Sponsor study identifier
Secondary identifiers
REGISTRY · NCI CTRP
OTHER · NCI
interventional
233
1 country
1
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2014
Actual (reported)Study Completion
November 2014
Actual (reported)The goal of this clinical research study is to learn if giving busulfan in a dose based on blood levels, along with a fixed (unchanging) dose of fludarabine, is more effective and causes fewer side effects for AML or myelodysplastic syndrome patients than the standard method of giving a fixed busulfan dose based on body size, along with a fixed dose of fludarabine. The safety of dosing based on blood levels will also be studied.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
May 3, 2007
Actual (reported)May 4, 2007
Actual (reported)November 2014
Actual (reported)November 2014
Actual (reported)January 19, 2021
Actual (reported)Treatment-related Mortality (TRM)
Time to failure (TTF) defined as either disease recurrence or death, from the time of bone marrow transplant (BMT) and reported as TRM at 100 days and 1 year. Treatment period defined as BMT Day -9 for patients treated on the PK-guided treatment arm, and day -7 for patients receiving the fixed-dose busulfan treatment through BMT Day +28. The post study surveillance period is defined as BMT Day +29 through BMT Day +100. Bone marrow aspirate with cytogenetics at approximately one (1) month and three (3) months, or as clinically indicated. Response Criteria is measured by the bone marrow aspirate to determine it has leukemic blast. Bone marrow blast less than 5% is considered to be a complete response.
From transplant at Day 0 to Day 100 and 1 year following transplant
3 Year Progression Free Survival
PFS defined as length of time either due to disease recurrence or death, from the time of stem cell infusion (Bone marrow or PBPC) to 3 years. Response Criteria is measured by the bone marrow aspirate to determine it has leukemic blast. Bone marrow blast less than 5% is considered to be a complete response.
3 years
Busulfan Fixed Dose = 130 mg/m\^2 IV Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
Busulfan Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m\^2 IV Daily Over 1 Hour x 4 Days.
Fixed Dose = 130 mg/m\^2 IV Daily Over Three Hours x 4 Days. Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day. Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.
40 mg/m\^2 IV Daily Over 1 Hour x 4 Days
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Richard E. Champlin, MD
M.D. Anderson Cancer Center
233 participants (actual enrollment reported by the registry).
First Submitted
May 3, 2007
First Posted
May 4, 2007
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Clinical Phase III Trial Treosulfan-based Conditioning Versus Reduced-intensity Conditioning (RIC)
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Primary Completion
November 2014
Actual (reported)Study Completion
November 2014
Actual (reported)Last Updated
January 19, 2021
Results First Posted
January 19, 2021
Record last verified: 2021-01
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Source: ClinicalTrials.gov.
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