|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Center for Research Resources (NCRR) |
|---|---|
| Collaborator: |
University of California, Los Angeles |
| Information provided by: | National Center for Research Resources (NCRR) |
| ClinicalTrials.gov Identifier: | NCT00004323 |
Purpose
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: | Endpoint Classification: Efficacy Study Primary Purpose: Treatment |
| 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.
Eligibility| 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
Contacts and Locations| United States, California | |
| Center for Health Sciences | |
| Los Angeles, California, United States, 90024-1714 | |
| Study Chair: | Mary Carol Territo | University of California, Los Angeles |
More Information
| ClinicalTrials.gov Identifier: | NCT00004323 History of Changes |
| Other Study ID Numbers: | 199/11863, UCLA-94020602 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
|
aplastic anemia hematologic disorders rare disease |
|
Anemia Anemia, Aplastic Hematologic Diseases Bone Marrow Diseases Antilymphocyte Serum Cyclophosphamide Cyclosporins Cyclosporine Methotrexate Methylprednisolone Hemisuccinate Prednisolone Methylprednisolone acetate Prednisolone acetate Methylprednisolone Prednisolone phosphate |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Enzyme Inhibitors Antifungal Agents Anti-Infective Agents Dermatologic Agents |