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

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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. Last updated on September 8, 2008. Information provided by Office of Rare Diseases (ORD)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

Treatment, Single Group Assignment

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

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

Intervention ^†

Drug: cyclophosphamide
Drug: filgrastim

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

March 1999

Completion Date

Eligibility 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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00010387

Organization ID

199/15672

Secondary IDs ^††

JHOC-J9881, JHOC-99012906

Study Sponsor ^†

Johns Hopkins University

Collaborators ^††

Investigators ^†

Study Chair:

Robert A. Brodsky

Johns Hopkins University

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

September 2008

First Received Date ^†

February 2, 2001

Last Updated Date

September 8, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.