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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Genzyme |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00469014 |
Purpose
The goal of this clinical research study is to find the best dose of clofarabine and fludarabine that can be given with busulfan followed by an allogeneic blood stem cell transplant. Researchers will study whether this combination can help to control the disease, and look at the safety of this combination. Researchers also want to find out if combining busulfan with clofarabine alone or combining busulfan with both fludarabine and clofarabine will improve the treatment, compared with the previous standard method using busulfan and fludarabine alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia Myelodysplastic Syndrome Chronic Myeloid Leukemia |
Drug: Clofarabine Drug: Busulfan Drug: Fludarabine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Busulfan-Fludarabine-Clofarabine With Allogeneic Stem Cell Transplantation for Advanced Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Advanced, Gleevec Refractory Chronic Myeloid Leukemia. A Randomized Phase II Study. |
| Estimated Enrollment: | 70 |
| Study Start Date: | September 2006 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Busulfan + Fludarabine + Clofarabine
|
Drug: Clofarabine
Arm 1 = 10 mg/m^2 IV Daily; Arm 2 = 20 mg/m^2 IV Daily; Arm 3 = 30 mg/m^2 IV Daily; Arm 4 = 40 mg/m^2 IV Daily
Other Names:
Drug: Busulfan
Arm 1: 30 mg/m^2 IV Daily; Arm 2: 20 mg/m^2 IV Daily; Arm 3: 10 mg/m^2 IV Daily; Arm 4: 40 mg/m^2 IV Daily
Other Names:
Drug: Fludarabine
Arm 1: 30 mg/m^2 IV Daily; Arm 2: 20 mg/m^2 IV Daily; Arm 3: 10 mg/m^2 IV Daily
Other Names:
|
|
Experimental: 2
Busulfan + Fludarabine + Clofarabine
|
Drug: Clofarabine
Arm 1 = 10 mg/m^2 IV Daily; Arm 2 = 20 mg/m^2 IV Daily; Arm 3 = 30 mg/m^2 IV Daily; Arm 4 = 40 mg/m^2 IV Daily
Other Names:
Drug: Busulfan
Arm 1: 30 mg/m^2 IV Daily; Arm 2: 20 mg/m^2 IV Daily; Arm 3: 10 mg/m^2 IV Daily; Arm 4: 40 mg/m^2 IV Daily
Other Names:
Drug: Fludarabine
Arm 1: 30 mg/m^2 IV Daily; Arm 2: 20 mg/m^2 IV Daily; Arm 3: 10 mg/m^2 IV Daily
Other Names:
|
|
Experimental: 3
Busulfan + Fludarabine + Clofarabine
|
Drug: Clofarabine
Arm 1 = 10 mg/m^2 IV Daily; Arm 2 = 20 mg/m^2 IV Daily; Arm 3 = 30 mg/m^2 IV Daily; Arm 4 = 40 mg/m^2 IV Daily
Other Names:
Drug: Busulfan
Arm 1: 30 mg/m^2 IV Daily; Arm 2: 20 mg/m^2 IV Daily; Arm 3: 10 mg/m^2 IV Daily; Arm 4: 40 mg/m^2 IV Daily
Other Names:
Drug: Fludarabine
Arm 1: 30 mg/m^2 IV Daily; Arm 2: 20 mg/m^2 IV Daily; Arm 3: 10 mg/m^2 IV Daily
Other Names:
|
|
Experimental: 4
Busulfan + Clofarabine
|
Drug: Clofarabine
Arm 1 = 10 mg/m^2 IV Daily; Arm 2 = 20 mg/m^2 IV Daily; Arm 3 = 30 mg/m^2 IV Daily; Arm 4 = 40 mg/m^2 IV Daily
Other Names:
Drug: Busulfan
Arm 1: 30 mg/m^2 IV Daily; Arm 2: 20 mg/m^2 IV Daily; Arm 3: 10 mg/m^2 IV Daily; Arm 4: 40 mg/m^2 IV Daily
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Richard E. Champlin, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00469014 History of Changes |
| Other Study ID Numbers: | 2006-0200 |
| Study First Received: | May 3, 2007 |
| Last Updated: | September 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Acute Myeloid Leukemia AML Myelodysplastic Syndrome MDS Chronic Myeloid Leukemia CML Busulfan Busulfex Myleran Fludarabine |
Fludara Fludarabine Phosphate Clofarabine Clofarex Clolar Allogeneic stem cell transplantation ASCT Stem Cell Gleevec Imatinib Mesylate |
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Busulfan Fludarabine monophosphate Fludarabine |
Clofarabine Vidarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents |