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.

Completed

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Key information

Conditions

Anemia, Hemolytic, Autoimmune Anemia Anemia, Hemolytic Arthritis Arthritis, Rheumatoid Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Connective Tissue Diseases Cytopenia Disease Attributes Felty Syndrome Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Rare Diseases Rheumatic Diseases Signs and Symptoms Skin Manifestations Skin and Connective Tissue Diseases Thrombocytopenia Thrombotic Microangiopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

Filgrastim

Drug

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start: 1999
Primary completion: 2007
First posted: Feb 2, 2001
Registry last updated: Sep 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed