Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease
NCT ID: NCT00010387
Last Updated: 2008-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
32 participants
INTERVENTIONAL
1999-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cyclophosphamide
filgrastim
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Johns Hopkins University
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert A. Brodsky
Role: STUDY_CHAIR
Johns Hopkins University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JHOC-J9881
Identifier Type: -
Identifier Source: secondary_id
JHOC-99012906
Identifier Type: -
Identifier Source: secondary_id
199/15672
Identifier Type: -
Identifier Source: org_study_id