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Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease
This study has been completed.
Study NCT00010387   Information provided by Office of Rare Diseases (ORD)
First Received: February 2, 2001   Last Updated: September 8, 2008   History of Changes

February 2, 2001
September 8, 2008
March 1999
August 2007   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00010387 on ClinicalTrials.gov Archive Site
 
 
 
Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease
 

OBJECTIVES:

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

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.

Phase II
Interventional
Treatment, Single Group Assignment
  • Anemia, Hemolytic, Autoimmune
  • Felty Syndrome
  • Purpura, Thrombocytopenic
  • Autoimmune Diseases
  • Drug: cyclophosphamide
  • Drug: filgrastim
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
32
 
August 2007   (final data collection date for primary outcome measure)

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010387
 
199/15672, JHOC-J9881, JHOC-99012906
Johns Hopkins University
 
Study Chair: Robert A. Brodsky Johns Hopkins University
Office of Rare Diseases (ORD)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP