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| Sponsored by: |
Johns Hopkins University |
|---|---|
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004464 |
Purpose
OBJECTIVES: I. Confirm the efficacy demonstrated in a pilot study using high dose cyclophosphamide in patients with severe aplastic anemia.
II. Determine whether the addition of filgrastim (G-CSF) to high dose cyclophosphamide shortens the time to recovery in these patients.
III. Determine whether this regimen is efficacious in treating paroxysmal nocturnal hemoglobinuria.
| Condition | Intervention |
|---|---|
|
Aplastic Anemia Paroxysmal Hemoglobinuria, Nocturnal |
Drug: cyclophosphamide Drug: filgrastim |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Estimated Enrollment: | 25 |
| Study Start Date: | February 1996 |
PROTOCOL OUTLINE: Patients receive high dose cyclophosphamide IV on days 1-4. Beginning on day 10, patients receive filgrastim (G-CSF) until the absolute neutrophil count is greater than 1,000/mm3 for 2 consecutive days. Patients are followed every 3 months for at least 2 years and annually thereafter.
Eligibility| Ages Eligible for Study: | up to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Acquired severe aplastic anemia or paroxysmal nocturnal hemoglobinuria Not a candidate for allogeneic bone marrow transplantation Must meet one of the following criteria: - Severe aplastic anemia Less than 25% bone marrow cellularity and depression in two of three blood counts (reticulocytes less than 40,000/mm3, platelet count less than 20,000/mm3 and granulocytes less than 500/mm3) - Life-threatening paroxysmal nocturnal hemoglobinuria Absolute neutrophil count less than 500/mm3, platelet transfusion dependent, or thrombotic disease No Fanconi anemia No abnormal cytogenetics --Patient Characteristics-- Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Cardiac ejection fraction at least 45% Other: Not preterminal or moribund Not pregnant
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Oncology Center | |
| Baltimore, Maryland, United States, 21231 | |
| Study Chair: | Robert A. Brodsky | Johns Hopkins University |
More Information
| Study ID Numbers: | 199/13895, JHOC-96011702, JHOC-9611 |
| Study First Received: | October 18, 1999 |
| Last Updated: | March 28, 2007 |
| ClinicalTrials.gov Identifier: | NCT00004464 History of Changes |
| Health Authority: | Unspecified |
|
aplastic anemia hematologic disorders paroxysmal nocturnal hemoglobinuria rare disease |
|
Immunologic Factors Aplastic Anemia Hematologic Diseases Urination Disorders Myelodysplastic Syndromes Marchiafava-Micheli Disease Anemia Rare Diseases Anemia, Hemolytic Cyclophosphamide Immunosuppressive Agents Hemoglobinuria |
Signs and Symptoms Proteinuria Preleukemia Paroxysmal Nocturnal Hemoglobinuria Urologic Diseases Anemia, Aplastic Hemoglobinuria, Paroxysmal Antineoplastic Agents, Alkylating Antirheumatic Agents Bone Marrow Diseases Alkylating Agents |
|
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Signs and Symptoms Urologic Diseases Therapeutic Uses Hemoglobinuria, Paroxysmal Anemia, Aplastic Alkylating Agents Urination Disorders Hematologic Diseases |
Myelodysplastic Syndromes Anemia Anemia, Hemolytic Immunosuppressive Agents Pharmacologic Actions Urological Manifestations Hemoglobinuria Proteinuria Myeloablative Agonists Antineoplastic Agents, Alkylating Bone Marrow Diseases Antirheumatic Agents |
