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| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00343785 |
Purpose
RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide, before a donor bone marrow transplant helps stop the growth of abnormal cells. It also stops the patient's immune system from rejecting the donor's bone marrow. The donated bone marrow stem cells may replace the patient's immune system and help destroy any remaining abnormal cells. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a smaller than usual dose of bone marrow stem cells and giving antithymocyte globulin, cyclosporine and methotrexate before or after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with antithymocyte globulin followed by methotrexate and cyclosporine works in preventing chronic graft-versus-host disease in patients with severe aplastic anemia undergoing a reduced-dose donor bone marrow transplant.
| Condition | Intervention | Phase |
|---|---|---|
|
Graft Versus Host Disease Precancerous/Nonmalignant Condition |
Biological: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: methotrexate Procedure: allogeneic hematopoietic stem cell transplantation Procedure: bone marrow transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Cyclophosphamide and Antithymocyte Globulin Conditioning Regimen for Marrow Transplantation From HLA-Matched Family Members for Severe Aplastic Anemia: Effect of Marrow Cell Dose on Chronic Graft-vs.-Host Disease: A Multi-Center Trial |
| Estimated Enrollment: | 150 |
| Study Start Date: | February 2006 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive cyclophosphamide IV over 1-2 hours on days -5 to -2 and antithymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo an allogeneic reduced-dose bone marrow transplantation on day 0. Patients also receive methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or orally twice daily on days -1 to 50, followed by a taper.
After completion of study treatment, patients are followed for 100 days and then annually thereafter.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of aplastic anemia with marrow failure, meeting 2 of the following criteria:
No severe disease other than aplastic anemia that would severely limit the probability of survival during the graft procedure, including any of the following:
PATIENT CHARACTERISTICS:
No severe organ toxicities, including any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |
| Children's Hospital and Research Center Oakland | Recruiting |
| Oakland, California, United States, 94609 | |
| Contact: Clinical Trial Office - Children's Hospital and Research Cente 510-450-7600 | |
| United States, New Jersey | |
| Hackensack University Medical Center Cancer Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Scott D. Rowley, MD, FACP 201-996-5900 | |
| United States, Utah | |
| Huntsman Cancer Institute at University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: Michael A. Pulsipher, MD 801-585-3229 michael.pulsipher@hsc.utah.edu | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Rainer F. Storb, MD 206-667-4407 | |
| United States, Wisconsin | |
| Medical College of Wisconsin Cancer Center | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380 | |
| Principal Investigator: | Rainer F. Storb, MD | Fred Hutchinson Cancer Research Center |
More Information
| Responsible Party: | Fred Hutchinson Cancer Research Center ( Rainer F. Storb ) |
| Study ID Numbers: | CDR0000480733, FHCRC-2054.00 |
| Study First Received: | June 22, 2006 |
| Last Updated: | March 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00343785 History of Changes |
| Health Authority: | Unspecified |
|
graft versus host disease aplastic anemia |
|
Antimetabolites Cyclosporine Precancerous Conditions Immunologic Factors Aplastic Anemia Clotrimazole Miconazole Cyclophosphamide Cyclosporins Graft Versus Host Disease Antifungal Agents Anemia, Aplastic Methotrexate |
Alkylating Agents Hematologic Diseases Anemia Tioconazole Folic Acid Antagonists Immunosuppressive Agents Homologous Wasting Disease Antilymphocyte Serum Folic Acid Graft vs Host Disease Antineoplastic Agents, Alkylating Bone Marrow Diseases Antirheumatic Agents |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Precancerous Conditions Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Cyclophosphamide Cyclosporins Antifungal Agents Therapeutic Uses Abortifacient Agents |
Anemia, Aplastic Methotrexate Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Immune System Diseases Hematologic Diseases Anemia Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Antilymphocyte Serum Neoplasms |
