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Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic Anemia

This study has been completed.
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00004323
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: April 2002
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 10
Study Start Date: February 1995
Detailed Description:

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   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00004323

Locations
United States, California
Center for Health Sciences
Los Angeles, California, United States, 90024-1714
Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of California, Los Angeles
Investigators
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

Keywords provided by National Center for Research Resources (NCRR):
aplastic anemia
hematologic disorders
rare disease

Additional relevant MeSH terms:
Anemia
Anemia, Aplastic
Hematologic Diseases
Bone Marrow Diseases
Cyclophosphamide
Cyclosporins
Cyclosporine
Methotrexate
Antilymphocyte Serum
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Calcineurin Inhibitors

ClinicalTrials.gov processed this record on May 24, 2017