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

Tracking Information

First Received Date ^ICMJE

February 2, 2001

Last Updated Date

September 8, 2008

Start Date ^ICMJE

March 1999

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00010387 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Single Group Assignment

Condition ^ICMJE

Anemia, Hemolytic, Autoimmune
Felty Syndrome
Purpura, Thrombocytopenic
Autoimmune Diseases

Intervention ^ICMJE

Drug: cyclophosphamide
Drug: filgrastim

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00010387

Responsible Party

Study ID Numbers ^ICMJE

199/15672, JHOC-J9881, JHOC-99012906

Study Sponsor ^ICMJE

Johns Hopkins University

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Robert A. Brodsky

Johns Hopkins University

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

September 2008

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