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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Heart, Lung, and Blood Institute (NHLBI) National Cancer Institute (NCI) |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00474747 |
Primary Objectives (Phase I):
Primary Objective (Phase II):
1. Two-year post-transplant survival achieved with the level of CY dose reduction selected in the dose-finding portion of the study.
Secondary Objective:
1. Secondary graft failure and acute and chronic graft-versus-host disease (GVHD).
Condition | Intervention | Phase |
---|---|---|
Aplastic Anemia |
Drug: Antithymocyte Globulin Drug: Cyclophosphamide Drug: Fludarabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Fludarabine-Based Conditioning for Allogeneic Marrow Transplantation From HLA-Compatible Unrelated Donors in Severe Aplastic Anemia |
Estimated Enrollment: | 78 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Fludarabine + Antithymocyte Globulin + Cyclophosphamide
|
Drug: Antithymocyte Globulin
3 mg/kg IV over no less than four (and preferably six) hours daily x 3 days
Drug: Cyclophosphamide
50 mg/kg IV x 3 days
Drug: Fludarabine
30 mg/m^2 IV over no less than 30 minutes daily x 4 days
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Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients up to 65 years of age at time of registration with a diagnosis of severe aplastic anemia (SAA). SAA is defined as follows:
Patients with adequate organ function as measured by:
Exclusion Criteria:
Contact: Paolo Anderlini, MD | 713-792-8750 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Paolo Anderlini, MD |
Principal Investigator: | Paolo Anderlini, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Paolo Anderlini, MD/Associate Professor ) |
Study ID Numbers: | 2005-0513 |
Study First Received: | May 16, 2007 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00474747 History of Changes |
Health Authority: | United States: Institutional Review Board |
Severe Aplastic Anemia Total Body Irradiation Antithymocyte Globulin Cyclophosphamide Cytoxan Neosar Fludarabine |
Fludarabine Phosphate Thymoglobulin ATG TBI Cyclosporine Tacrolimus |
Antimetabolites Cyclosporine Immunologic Factors Hematologic Diseases Aplastic Anemia Anemia Cyclophosphamide Fludarabine monophosphate Tacrolimus |
Cyclosporins Immunosuppressive Agents Antilymphocyte Serum Anemia, Aplastic Antineoplastic Agents, Alkylating Fludarabine Antirheumatic Agents Bone Marrow Diseases Alkylating Agents |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Hematologic Diseases Physiological Effects of Drugs Anemia Cyclophosphamide Fludarabine monophosphate Immunosuppressive Agents |
Pharmacologic Actions Antilymphocyte Serum Therapeutic Uses Myeloablative Agonists Anemia, Aplastic Antineoplastic Agents, Alkylating Fludarabine Bone Marrow Diseases Antirheumatic Agents Alkylating Agents |