IRB #

IRB00002975

Title

CTN 0301: Fludarabine-based Conditioning for Allogeneic Marrow Transplantation From HLA-compatible Unrelated Donors in Severe Aplastic Anemia

Principal Investigator

Gabrielle Meyers

Study Purpose

The purpose of this study is to determine what dosing of cyclophosphamide, in combination with fludarabine, will best reduce the problems from transplant while still allowing engraftment in those with aplastic anemia. There are four dosing groups in the study. Each group receives the same amount of fludarabine, but a smaller dose of cyclosporine than the group before them, depending on the previous group's experience.

Medical Condition(s)

Other Hematopoietic

Eligibility Criteria

*Diagnoses of severe aplastic anemia 
*Under 65 y/o at registration 
*7/8 or 8/8 unrelated donor match 
*MUD must provide marrow allograft 
*Adequate organ function as determined by pre-transplant workup 
*Karnofsky must be >60% 
*No clonal abnormalities associated with MDS or AML on marrow 
*No diagnoses of other congenital aplastic anemias 
*No symtomatic or uncontrolled cardiac failure or coronary cardiac disease 
*No uncontrolled bacterial, viral or fungal infections,
*Cannot be HIV positive 
*Cannot be pregnant or breastfeeding 
*No known allergy or intolerance to ATG or cyclosporine/tacrolimus 
*No pleural effusions or ascites which would be a contraindiction for methotrexate GVHD prophytlaxis 
*No prior allogeneic SC or marrow transplants 
*No prior administration of investigational agents as alternatives to GVHD prophylaxis  *Cannot also be enrolled in a Phase I study

Age Range

1 month - 65

Healthy Volunteers Needed

Yes

Duration of Participation

Minors Included

Yes

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Bone Marrow Transplantation Clinical Trials Network

Recruitment End

Compensation Provided

No