search
Back to results

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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cyclophosphamide
filgrastim
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia, Hemolytic, Autoimmune focused on measuring Felty syndrome, autoimmune hemolytic anemia, autoimmune neutropenia, hematologic disorders, immune thrombocytopenic purpura, rare disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Oncology Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
September 8, 2008
Sponsor
Johns Hopkins University
search

1. Study Identification

Unique Protocol Identification Number
NCT00010387
Brief Title
Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Johns Hopkins University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Hemolytic, Autoimmune, Felty Syndrome, Purpura, Thrombocytopenic, Autoimmune Diseases
Keywords
Felty syndrome, autoimmune hemolytic anemia, autoimmune neutropenia, hematologic disorders, immune thrombocytopenic purpura, rare disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
32 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
filgrastim

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A. Brodsky
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
Facility Information:
Facility Name
Johns Hopkins Oncology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs