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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00258427 |
RATIONALE: A peripheral stem cell, bone marrow, or umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Giving combination chemotherapy before a donor stem cell transplant may make the transplant more likely to work. This may be an effective treatment for Fanconi's anemia.
PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating patients who are undergoing a donor stem cell transplant for Fanconi's anemia.
Condition | Intervention |
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Fanconi Anemia Graft Versus Host Disease |
Drug: anti-thymocyte globulin Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: filgrastim Drug: fludarabine phosphate Drug: methylprednisolone Drug: mycophenolate mofetil Procedure: allogeneic bone marrow transplantation Procedure: graft-versus-tumor induction therapy Procedure: peripheral blood stem cell transplantation Procedure: umbilical cord blood transplantation |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Hematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi Anemia MT2002-02 |
Estimated Enrollment: | 25 |
Study Start Date: | March 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to donor/recipient HLA type (identical vs other).
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Ages Eligible for Study: | up to 44 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of high-risk Fanconi's anemia, as defined by ≥ 1 of the following:
Advanced myelodysplastic syndromes (MDS)
Has a related or unrelated donor available that meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Not specified
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 |
Study Chair: | Margaret L. MacMillan, MD | Masonic Cancer Center, University of Minnesota |
Study ID Numbers: | CDR0000450841, UMN-2002LS014, UMN-MT2002-02 |
Study First Received: | November 22, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00258427 |
Health Authority: | Unspecified |
graft versus host disease Fanconi anemia |
Cyclosporine Clotrimazole Graft versus host disease Methylprednisolone Miconazole Prednisolone acetate Cyclophosphamide Cyclosporins Fanconi's anemia Anemia, Aplastic Mycophenolate mofetil Methylprednisolone Hemisuccinate Metabolic Diseases Hematologic Diseases Fanconi Anemia |
Tioconazole Anemia Methylprednisolone acetate Fludarabine monophosphate Homologous wasting disease Antilymphocyte Serum Genetic Diseases, Inborn Busulfan Prednisolone Graft vs Host Disease Fludarabine Metabolic disorder Aplastic anemia Bone Marrow Diseases |
Antimetabolites Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs DNA Repair-Deficiency Disorders Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Neuroprotective Agents Therapeutic Uses Antifungal Agents |
Alkylating Agents Dermatologic Agents Antineoplastic Agents, Hormonal Immune System Diseases Gastrointestinal Agents Enzyme Inhibitors Glucocorticoids Protective Agents Immunosuppressive Agents Pharmacologic Actions Anemia, Hypoplastic, Congenital Autonomic Agents Myeloablative Agonists Antineoplastic Agents, Alkylating Peripheral Nervous System Agents |