Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia - Tabular View

Tracking Information
First Received Date ^ICMJE	October 18, 1999
Last Updated Date	October 1, 2008
Start Date ^ICMJE	September 1998
Primary Completion Date	August 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 1, 2008)	Graft failure, graft versus host disease, and survival [ Time Frame: Measured at Day 100, Month 6, and Year 1 post-transplant ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00004474 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia
Official Title ^ICMJE	Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia
Brief Summary	OBJECTIVES: I. Compare outcome, including graft failure, graft versus host disease, and survival of HLA-identical sibling bone marrow transplants for aplastic anemia using cyclophosphamide with or without antithymocyte globulin as a conditioning regimen.
Detailed Description	PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive cyclophosphamide IV over 60 minutes on days -5 to -2 with or without antithymocyte globulin IV over 4 hours. All patients then receive bone marrow over 60-120 minutes on day 0, 36 hours after the last dose of cyclophosphamide. Patients are followed at day 100, at 6 months, and at 1 year posttransplant.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Aplastic Anemia
Intervention ^ICMJE	Drug: Anti-thymocyte globulin Drug: Cyclophosphamide Procedure: Bone marrow transplantation
Study Arms / Comparison Groups	Experimental: Participants will receive cyclophosphamide IV over 60 minutes on Days -5 to -2 with antithymocyte globulin IV over 4 hours; then, after the last does cycophosphamide, participants will receive a bone marrow transplant over 60 to 120 minutes on Day 0. Experimental: Participants will receive cyclophosphamide IV over 60 minutes on Days -5 to -2; then, after the last does cycophosphamide, participants will receive a bone marrow transplant over 60 to 120 minutes on Day 0.
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	224
Completion Date	August 2007
Primary Completion Date	August 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Severe aplastic anemia with the following criteria: Hypocellular bone marrow with cellularity less than 20% At least 2 of the following hematologic abnormalities: Neutrophil count no greater than 500/mm3 Platelet count no greater than 20,000/mm3 Reticulocyte count no greater than 50,000/mm3 HLA-identical sibling donor available No clonal cytogenetic abnormalities, paroxysmal nocturnal hemoglobinuria, or myelodysplastic syndrome within 3 months of diagnosis of aplastic anemia No congenital or constitutional aplastic anemia or Fanconi anemia --Patient Characteristics-- Hepatic: Bilirubin less than 3 times upper limit of normal (ULN) Renal: Creatinine less than 2 times ULN Cardiovascular: Normal cardiac function Other: No uncontrolled infection No severe concurrent disease HIV negative Fertile patients must use effective contraception
Gender	Both
Ages	up to 59 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00004474
Responsible Party	Richard Champlin, University of Texas - MD Anderson Cancer Center
Study ID Numbers ^ICMJE	199/14004, RPCI-RP-9804, NCI-G98-1491, IBMTR-1
Study Sponsor ^ICMJE	Roswell Park Cancer Institute
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Office of Rare Diseases (ORD)
Verification Date	October 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP