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Bone Marrow Transplant

Fludarabine-based Conditioning for Severe Aplastic Anemia (FHCRC-2051)
Fludarabine-based Conditioning for Allogeneic Marrow Transplantation from HLA-compatible Unrelated Donors in Severe Aplastic Anemia
Status Conditions Phase Study ID
Recruiting Aplastic Anemia; Bone Marrow and Hematopoietic Stem Cell Transplant (BMT and HSCT); Non-malignant Condition Phase I/II FHCRC-2051
NCT00326417
Summary

This is an unrelated donor transplantation study for patients up to age 65 with severe aplastic anemia.The purpose of this study is to determine what dose of cyclophosphamide should be used, along with other medications before transplantation, to improve the safety and effectiveness of transplantation.

The chemotherapy and irradiation given just before a transplant is called the conditioning regimen. Participants in this study will receive a conditioning regimen consisting of fludarabine, cyclophosphamide, and antithymocyte globulin (ATG), as well as low-dose total body irradiation.

Different groups of participants will receive different amounts of cyclophosphamide, of which they will be informed.

Study participants will then receive a bone marrow transplant using cells from an unrelated donor.

Most of the care will be given at the Seattle Cancer Care Alliance (SCCA) outpatient clinic. During the transplant and the initial recovery period, and if needed at different time points after the transplant, participants will be admitted to the UW Medical Center hospital.

Participants will be asked to come to the SCCA clinic on a regular basis for exams and blood tests for about 3 months after the transplant. Participants will be followed by their personal physicians for up to 2 years.


Investigator
Joachim Deeg, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

1. Patient is 65 years of age or younger.

2. Patient has a diagnosis of Severe Aplastic Anemia.

3. Patient has a suitable, unrelated donor. (The donor cannot be a family member.)

4. Patient may be either female or male.

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

1. Clonal cytogenetic abnormalities associated with MDS or AML on marrow examination.

2. Diagnosis of Fanconi anemia.

3. Diagnosis of other ?congenital? marrow failure states (such as Diamond-Blackfan, Shwachmann-Diamond, congenital amegakaryocytosis).

4. Symptomatic or uncontrolled heart failure or coronary artery disease.

5. Uncontrolled infection.

6. Blood test results show presence of HIV infection.

7. Pregnancy or breastfeeding.

8. Known allergy to ATG, cyclosporine or tacrolimus.

9. Patient is also enrolled in another phase I study.

10. Patient has had a prior allogeneic marrow or stem cell transplant.

11. Patient has had a prior malignancy, except resected basal cell carcinoma or treated carcinoma in-situ.

Other exclusion criteria may apply.

Last Updated
November 04, 2010
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.