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Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease

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ClinicalTrials.gov Identifier: NCT00010387
Recruitment Status : Completed
First Posted : February 2, 2001
Last Update Posted : September 10, 2008
Sponsor:
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:

OBJECTIVES:

I. Determine the response rate and 1-year event-free survival in patients with severe autoimmune hematologic disease treated with high-dose cyclophosphamide.


Condition or disease Intervention/treatment Phase
Anemia, Hemolytic, Autoimmune Felty Syndrome Purpura, Thrombocytopenic Autoimmune Diseases Drug: cyclophosphamide Drug: filgrastim Phase 2

Detailed Description:

PROTOCOL OUTLINE: Patients receive high-dose cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) starting on day 10 and continuing until blood counts recover.

Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.


Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Study Start Date : March 1999
Actual Primary Completion Date : August 2007






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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Diagnosis of severe autoimmune hematologic disease Autoimmune hemolytic anemia OR Immune thrombocytopenia
  • Failure of at least 2 standard treatment approaches (e.g., prednisone therapy, splenectomy, intravenous immunoglobulin, or other immunosuppressants)
  • Inability to taper prednisone dose to less than 10 mg/day OR Autoimmune neutropenia including the following: Felty's syndrome OR Disorders of large granular lymphocytes with recurrent infections or absolute neutrophil count less than 200/mm3

--Prior/Concurrent Therapy--

  • See Disease Characteristics

--Patient Characteristics--

  • Age: Not specified
  • Performance status: Not specified
  • Hematopoietic: See Disease Characteristics
  • Hepatic: Not specified
  • Renal: Creatinine no greater than 2.5 mg/dL
  • Cardiovascular: Ejection fraction at least 40%
  • Pulmonary: FVC, FEV1, or DLCO at least 50% predicted

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Not preterminal or moribund

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010387


Locations
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Johns Hopkins University
Investigators
Study Chair: Robert A. Brodsky Johns Hopkins University

ClinicalTrials.gov Identifier: NCT00010387     History of Changes
Other Study ID Numbers: 199/15672
JHOC-J9881
JHOC-99012906
First Posted: February 2, 2001    Key Record Dates
Last Update Posted: September 10, 2008
Last Verified: September 2008

Keywords provided by Office of Rare Diseases (ORD):
Felty syndrome
autoimmune hemolytic anemia
autoimmune neutropenia
hematologic disorders
immune thrombocytopenic purpura
rare disease

Additional relevant MeSH terms:
Purpura
Autoimmune Diseases
Hemolysis
Purpura, Thrombocytopenic
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Felty Syndrome
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Immune System Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Anemia
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating