Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
M.D. Anderson Cancer Center |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00469144 |
Primary Objectives:
To determine if busulfan (Bu) given in pharmacokinetically adjusted dose to yield a blood daily AUC of 6,000 microMol-min is superior to a fixed dose of 130 mg/m2 to prevent treatment failure (relapse or death from any cause) in patients with acute myelogenous leukemia and myelodysplastic syndrome.
This dose will be given intravenously over three hours once daily for four (4) days, each dose preceded by Fludarabine at a dose of 40 mg/m2, as preparation for bone marrow or peripheral blood progenitor cell transplantation.
Condition | Intervention | Phase |
---|---|---|
Myelodysplastic Syndrome Leukemia Acute Myeloid Leukemia |
Drug: Busulfan Drug: Fludarabine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Study of Once Daily IV Busulfan With Fludarabine With Hemopoietic Stem Cell Transplantation for Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS) |
Estimated Enrollment: | 230 |
Study Start Date: | June 2005 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Fixed-Dose Busulfan + Fludarabine
|
Drug: Busulfan
Arm 1 = 130 mg/m^2 IV Daily Over Three Hours x 4 Days; Arm 2 = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Proceeding dosage level determined by pharmacokinetic studies to achieve a daily AUC of 6,000 microMol-min ± 10%.
Drug: Fludarabine
40 mg/m^2 IV Daily Over 1 Hour x 4 Days
|
2: Experimental
Adjusted Dose Busulfan + Fludarabine
|
Drug: Busulfan
Arm 1 = 130 mg/m^2 IV Daily Over Three Hours x 4 Days; Arm 2 = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Proceeding dosage level determined by pharmacokinetic studies to achieve a daily AUC of 6,000 microMol-min ± 10%.
Drug: Fludarabine
40 mg/m^2 IV Daily Over 1 Hour x 4 Days
|
Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria: None
Contact: Richard E. Champlin, MD | 713-792-8750 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Richard E. Champlin, MD |
Principal Investigator: | Richard E. Champlin, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Richard E. Champlin, MD/Chair ) |
Study ID Numbers: | 2005-0366 |
Study First Received: | May 3, 2007 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00469144 History of Changes |
Health Authority: | United States: Institutional Review Board |
Stem Cell Transplantation Leukemia Busulfan |
Fludarabine MDS AML |
Antimetabolites Immunologic Factors Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Leukemia, Myeloid Fludarabine monophosphate Leukemia, Myeloid, Acute Immunosuppressive Agents |
Leukemia Preleukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Busulfan Antineoplastic Agents, Alkylating Fludarabine Bone Marrow Diseases Alkylating Agents |
Antimetabolites Antimetabolites, Antineoplastic Precancerous Conditions Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid, Acute Leukemia Preleukemia Pathologic Processes Syndrome Therapeutic Uses Alkylating Agents |
Disease Neoplasms by Histologic Type Hematologic Diseases Myelodysplastic Syndromes Leukemia, Myeloid Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Neoplasms Busulfan Myeloablative Agonists Fludarabine Antineoplastic Agents, Alkylating Bone Marrow Diseases |