Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of California, Los Angeles |
---|---|
Information provided by: | National Center for Research Resources (NCRR) |
ClinicalTrials.gov Identifier: | NCT00004323 |
OBJECTIVES: I. Evaluate the efficacy of related, HLA-identical bone marrow transplantation following cyclophosphamide (CTX) and antithymocyte globulin in patients with aplastic anemia.
II. Evaluate the efficacy of related, HLA-nonidentical bone marrow transplantation following CTX and total-body irradiation/total-lymphoid irradiation in patients with aplastic anemia.
Condition | Intervention | Phase |
---|---|---|
Aplastic Anemia |
Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: mesna Drug: methotrexate Drug: methylprednisolone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Efficacy Study |
Estimated Enrollment: | 10 |
Study Start Date: | February 1995 |
PROTOCOL OUTLINE: Patients with HLA-identical donors receive cyclophosphamide/mesna, antithymocyte globulin (ATG), and methylprednisolone (MePRDL), followed by allogeneic marrow transplantation.
Patients with HLA-nonidentical (5/6 or 4/6) donors and those with a systemic reaction to ATG receive the same dosage of myeloablative chemotherapy and rescue. In addition, these patients are treated with total-body irradiation, total-lymphoid irradiation, and methotrexate. All patients received MePRDL and cyclosporine for graft-versus-host prophylaxis.
Ages Eligible for Study: | up to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Severe aplastic anemia with 2 of the following criteria: Polymorphonuclear neutrophils no more than 0.5 x 10 to the ninth/L Platelets no more than 20 x 10 to the ninth/L Reticulocytes no more than 30 x 10 to the ninth/L Hypocellular bone marrow
Related donor aged 6 weeks or more, matching at least 4 of 6 HLA A, B, and DRI loci, as follows:
HLA-identical family member for patients aged less than 40 years HLA-nonidentical family member for patients aged less than 55 years failing antithymocyte globulin or other immunosuppressive therapy The following eligible for transplantation as initial therapy: Patients aged less than 40 years with HLA-matched donor Patients aged 40-45 years with HLA-identical donor No neoplastic or preneoplastic evolution --Patient Characteristics-- Age: Under 40 (55 if ATG failure) Hepatic: No severe liver dysfunction Renal: No severe renal dysfunction Cardiovascular: No severe cardiac dysfunction Other: No other organ dysfunction that would compromise survival after transplant No HIV infection
United States, California | |
Center for Health Sciences | |
Los Angeles, California, United States, 90024-1714 |
Study Chair: | Mary Carol Territo | University of California, Los Angeles |
Study ID Numbers: | 199/11863, UCLA-94020602 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004323 History of Changes |
Health Authority: | United States: Federal Government |
aplastic anemia hematologic disorders rare disease |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Cyclosporine Immunologic Factors Methylprednisolone Aplastic Anemia Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Folate Antiemetics Prednisolone acetate Cyclophosphamide Hormones Neuroprotective Agents |
Cyclosporins Vitamin B9 Antifungal Agents Anemia, Aplastic Methotrexate Alkylating Agents Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Hematologic Diseases Rare Diseases Anemia Methylprednisolone acetate Folinic Acid Folic Acid Antagonists Glucocorticoids |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Immunologic Factors Molecular Mechanisms of Pharmacological Action Methylprednisolone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Reproductive Control Agents Cyclophosphamide |
Hormones Neuroprotective Agents Cyclosporins Antifungal Agents Therapeutic Uses Abortifacient Agents Anemia, Aplastic Methotrexate Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Hematologic Diseases Gastrointestinal Agents |