- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00010387
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21231
- Johns Hopkins Oncology Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Robert A. Brodsky, Johns Hopkins University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Hematologic Diseases
- Hemorrhage
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Anemia
- Blood Coagulation Disorders
- Skin Manifestations
- Thrombocytopenia
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Arthritis, Rheumatoid
- Purpura
- Purpura, Thrombocytopenic
- Autoimmune Diseases
- Hemolysis
- Anemia, Hemolytic
- Anemia, Hemolytic, Autoimmune
- Felty Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
Other Study ID Numbers
- 199/15672
- JHOC-J9881
- JHOC-99012906
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autoimmune Diseases
-
National Eye Institute (NEI)Completed
-
The Eye Center and The Eye Foundation for Research...CompletedAutoimmune Polyglandular Syndrome Type I | Autoimmune Keratitis
-
Sinocelltech Ltd.Not yet recruiting
-
TakedaCompletedAutoimmune DiseaseUnited Kingdom
-
Ziv HospitalUnknownAutoimmune DiseaseIsrael
-
National Institute of Allergy and Infectious Diseases...Immune Tolerance Network (ITN)TerminatedAutoimmune DisordersUnited States
-
Muğla Sıtkı Koçman UniversityCompletedMultiple Sclerosis | Telerehabilitation | Autoimmune Disorder | Exercise ProgramTurkey
-
Fundación Pública Andaluza Progreso y SaludKarolinska Institutet; Eli Lilly and Company; Medical University of Vienna; Sanofi and other collaboratorsCompletedSystemic Autoimmune DiseasesFrance, Belgium, Germany, Italy, Spain, Switzerland
-
Ruijin HospitalRecruiting
-
Jae Ho ByunGuerbetCompletedPancreatitis, Chronic | Autoimmune DiseaseKorea, Republic of
Clinical Trials on cyclophosphamide
-
Children's Hospital Los AngelesLucile Packard Children's HospitalTerminatedMetabolic Diseases | Stem Cell Transplantation | Chronic Granulomatous Disease | Bone Marrow Transplantation | Thalassemia | Wiskott-Aldrich Syndrome | Genetic Diseases | Peripheral Blood Stem Cell Transplantation | Pediatrics | Diamond-Blackfan Anemia | Allogeneic Transplantation | Combined Immune Deficiency | X-linked Lymphoproliferative Disease
-
Medical College of WisconsinNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute... and other collaboratorsCompletedAnemia, AplasticUnited States
-
Columbia UniversityUnknownSevere Combined Immunodeficiency | Fanconi Anemia | Bone Marrow Failure | OsteopetrosisUnited States
-
Mahidol UniversityTerminatedRenal Insufficiency | InfectionThailand
-
National Cancer Institute, NaplesImmatics Biotechnologies GmbH; CureVac; European Commission -FP7-Health-2013-Innovation-1CompletedHepatocellular CarcinomaBelgium, Germany, Italy, Spain, United Kingdom
-
Eisai Inc.CompletedBreast Cancer | Ovarian Cancer | Prostate Cancer | Colon Cancer | Renal CancerUnited States
-
Centre Oscar LambretCompleted
-
Merck KGaA, Darmstadt, GermanyCompleted
-
Baylor Research InstituteCompletedMalignant Melanoma Stage IVUnited States
-
University of Turin, ItalyUnknown