Busulfan and Fludarabine in Patients With AML and MDS
A Phase II Study of High-Dose Intravenous Busulfan and Fludarabine With Allogeneic Marrow and Peripheral Blood Progenitor Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes
1 other identifier
interventional
200
1 country
1
Brief Summary
Primary Objectives:
- 1.To administer multiple doses of an intravenous formulation of busulfan (Bu) at a dose adjusted to yield a blood drug level with a median daily area under the plasma concentration curve (AUC) of approximately 6,500 µMol-min. This dose will be given intravenously over three hours once daily for four (4) days, in combination with Fludarabine at a dose of 40 mg/m2 as preparation for bone marrow or peripheral stern cell transplantation in patients with acute myeloid leukemia or myelodysplastic syndromes.
- 2.To determine the outcome of Acute Myeloid Leukemia (AML)/myelodysplastic syndromes (MDS) patients undergoing treatment with this regimen. Data regarding engraftment, toxicity, relapse rate, long-term (disease-free) outcome, and overall survival will be collected.
- 3.To determine the safety profile of this regimen when utilized as preparation for allogeneic transplantation.
- 4.To describe the plasma pharmacokinetics of busulfan when administered intravenously in this regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 leukemia
Started Oct 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 16, 2007
CompletedFirst Posted
Study publicly available on registry
July 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
May 15, 2012
CompletedMay 28, 2012
May 1, 2012
5.1 years
July 16, 2007
April 17, 2012
May 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Successful Engraftment
Successful Engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 \* 10\^9/L. Failure to engraft by day +30 considered primary engraftment failure. Study period one week prior to transplant through post Day 28.
Study period one week prior to transplant through post Day 28
Study Arms (1)
Busulfan + Fludarabine
EXPERIMENTALOnce a day for four days, Busulfan 130 mg/m\^2 through intravenous catheter over 3 hours immediately after Fludarabine 40 mg/m\^2 over 1 hour.
Interventions
130 mg/m\^2 injected through the intravenous catheter over three hours, once a day, for four days, starting immediately after Fludarabine.
40 mg/m\^2 through a central venous catheter over one hour, once a day, for four days.
Eligibility Criteria
You may qualify if:
- Acute leukemia past first remission, in first or subsequent relapse, in first remission (high-risk, i.e., cytogenetics other than t(8;21, inv 16, t(15;17)) or induction failures.
- Myelodysplastic syndromes in any clinical stage, excluding only patients who have isolated stable mono-cytopenia and who are clinically stable.
- Patient has not been administered any other systemic chemotherapeutic drug (including Mylotarg) within 21 days prior to trial enrollment (BMT Day -7 or BMT day -9). (Hydroxyurea and intrathecal chemotherapy is permitted).
- No uncontrolled infection.
- Patients up to age 65 will be eligible for this study.
- ALLOGENEIC TRANSPLANTATION:
- Patients should have an acceptable related or unrelated volunteer donor available for a bone marrow peripheral blood progenitor cell or cord blood transplant. Bone marrow and peripheral blood cell donors should be matched for at least 5 of 6 HLA A, B and DR loci. Cord blood donors should be matched for at least 4 of 6 A, B and DR loci.
- Life expectancy is not severely limited.
- Pulmonary, cardio, renal and liver function tests normal.
- In patients \< 7 years pulmonary function will be assessed per pediatric BMT routine.
- No evidence of chronic active hepatitis or cirrhosis.
- HIV-negative.
- Female patient is not pregnant
- Signed informed consent.
- Patient admitted on Sunday, or Monday to allow for pharmacokinetic directed therapy.
You may not qualify if:
- \) Not fulfilling eligibility criteria above.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gabriela Rondon, MD / Assistant Professor
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Richard E. Champlin, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2007
First Posted
July 18, 2007
Study Start
October 1, 2003
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
May 28, 2012
Results First Posted
May 15, 2012
Record last verified: 2012-05