Status:
COMPLETED
IV Busulfan With Allo-BMT: Study for Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Myelodysplastic Syndrome
Leukemia
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE3
Brief Summary
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 ef...
Detailed Description
Busulfan is a chemotherapy drug that kills cancer cells by binding to DNA, and is commonly used in stem cell transplantation. Fludarabine is an antimetabolite drug which has anti-leukemia and immunosu...
Eligibility Criteria
Inclusion
- Acute myeloid leukemia past first remission, in first or subsequent relapse, in first remission (cytogenetics other than t(8;21, inv 16, t(15;17)) or induction failures. Only myeloid leukemia but not biphenotypic leukemia is allowed on this study.
- Myelodysplastic syndromes with intermediate or high risk International Prognostic Scoring System score
- Patient has not been administered any other systemic chemotherapeutic drug (including Mylotarg) within 21 days prior to trial enrollment (BMT Day -7 or day -9 for the test-dose arm of the study). Hydroxyurea is permitted if indicated to control induction refractory disease, and IT chemotherapy is allowed if indicated as maintenance treatment for previously diagnosed leptomeningeal disease, that has been in remission for at least 3 months prior to enrollment on this study).
- No active infection. Protocol PI will be final arbiter if there is uncertainty regarding whether a previous infection is resolved.
- age \<=65
- Patients must have a matched related or unrelated donor willing to donate. A donor who is HLA identical or mismatched in 1 locus on Class I \[HLA, A or B\], or molecularly mismatched in 1 locus on Class II \[HLA, DR or DQ\] is also acceptable.
- ZUBROD performance status \<2
- Life expectancy is not severely limited by concomitant illness and expected to be \>12 weeks.
- Left ventricular ejection fraction \>45% No uncontrolled arrhythmias or symptomatic cardiac disease.
- No symptomatic pulmonary disease. Forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO) \>/= 50% of expected corrected for hemoglobin. In patients \</= 7 years pulmonary function will be assessed per pediatric BMT routine
- Serum creatinine \</= 1.5 mg%.
- Serum glutamate pyruvate transaminase (SGPT) \</= 200 IU/ml, serum bilirubin and alkaline phosphatase within accepted laboratory standard normal limits or considered not clinically significant. No evidence of chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy.
- No effusion or ascites \>1L prior to drainage.
- HIV-negative.
- Female patient is not pregnant (negative B-human chorionic gonadotropin (HCG) pregnancy test in all women of child-bearing-potential in accordance with departmental routine).
- Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
- No prior autologous stem cell transplants
Exclusion
- 1\) None.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT00469144
Start Date
June 1 2005
End Date
November 1 2014
Last Update
January 19 2021
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030