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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00593645 |
This study will test the combination of clofarabine, cytarabine, and thymoglobulin as a non-myeloablative conditioning regimen for patients with myelodysplastic syndromes or acute myeloid leukemia undergoing allogeneic stem cell transplant.
Condition | Intervention | Phase |
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Myelodysplastic Syndromes Acute Myeloid Leukemia |
Drug: Clofarabine Drug: Cytarabine Drug: Thymoglobulin Procedure: Stem cell infusion |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Non-Myeloablative Conditioning Regimen for Allogeneic Transplantation With Clofarabine, Cytarabine, and Thymoglobulin for Myelodysplastic Syndrome and Acute Myeloid Leukemia |
Estimated Enrollment: | 20 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Clofarabine, Cytarabine and Thymoglobulin
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Drug: Clofarabine
Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2.
Drug: Cytarabine
Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
Drug: Thymoglobulin
Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
Procedure: Stem cell infusion
On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused.
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Current reduced intensity conditioning regimens have been able to decrease TRM (treatment related mortality) but suffer from increased rates of disease relapse. Disease burden at transplantation, as measured by percent myeloblasts, predicts relapse. Current regimens employ fludarabine and busulfan with various adjutants, but these agents are not part of the usual armamentarium used versus leukemia and have questionable anti-leukemic activity. By substituting clofarabine and cytarabine, a combination with proven anti-leukemic activity in the relapsed and refractory setting as well as activity versus MDS, as the back bone of the regimen we hope overcome residual disease and improve post-transplant relapse rates. Furthermore the principal toxicity of this regimen is myelosuppression, which should be abrogated by the infusion of stem cells. Thymoglobulin is included due to its minimal contribution to toxicity but significant benefits in engraftment, and controlling acute and chronic GVHD, which are major contributors to TRM and disease specific activity in MDS.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (Patient):
Myelodysplastic Syndrome (MDS), as defined by the World Health Organization criteria, OR Chronic Myelomonocytic Leukemia (CMML) as defined by the French American British classification OR Acute Myeloid Leukemia (AML) in complete remission [excluding FAB-M3] diagnosed by standard criteria and meet the criteria below:
Donor criteria:
Exclusion Criteria:
United States, Missouri | |
Ravi Vij, M.D. | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Ravi Vij, M.D. | Washington Universtiy of St. Louis |
Responsible Party: | Washington University School of Medicine ( Ravi Vij, M.D. ) |
Study ID Numbers: | 07-0702, No grant number |
Study First Received: | January 2, 2008 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00593645 History of Changes |
Health Authority: | United States: Institutional Review Board |
Conditioning regimens Stem Cell Transplantation Hematopoietic Stem Cell Transplantation Allogeneic Stem Cell Transplantation |
Nonmyeloablative conditioning Clofarabine Cytarabine Anti-thymocyte globulin |
Antimetabolites Clofarabine Immunologic Factors Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Leukemia, Myeloid Leukemia, Myeloid, Acute |
Antiviral Agents Immunosuppressive Agents Antilymphocyte Serum Leukemia Preleukemia Acute Myelocytic Leukemia Bone Marrow Diseases Cytarabine |
Antimetabolites Anti-Infective Agents 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 |
Cytarabine Clofarabine Disease Neoplasms by Histologic Type Hematologic Diseases Myelodysplastic Syndromes Leukemia, Myeloid Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Antilymphocyte Serum Neoplasms Bone Marrow Diseases |