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

This study has been completed.
Sponsor:
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00010387
First received: February 2, 2001
Last updated: September 8, 2008
Last verified: September 2008
History of Changes
  Purpose

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 Intervention Phase
Anemia, Hemolytic, Autoimmune
Felty Syndrome
Purpura, Thrombocytopenic
Autoimmune Diseases
 Drug: cyclophosphamide
Drug: filgrastim
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 32
Study Start Date: March 1999
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00010387     History of Changes
Other Study ID Numbers: 199/15672, JHOC-J9881, JHOC-99012906
Study First Received: February 2, 2001
Last Updated: September 8, 2008
Health Authority: Unspecified

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:
Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Autoimmune Diseases
Felty's Syndrome
Hematologic Diseases
Purpura
Hemolysis
Purpura, Thrombocytopenic
Immune System Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Connective Tissue Diseases
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Cyclophosphamide
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013