Status:
TERMINATED
G-CSF PMRD: Granulocyte Colony Stimulating Factor (G-CSF) Stimulated Bone Marrow and In Vivo T-Cell Depletion in Patients With Hematologic Malignancies or Bone Marrow Failure Syndrome
Lead Sponsor:
Emory University
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
Up to 22 years
Phase:
NA
Brief Summary
The purposes of this study are: * To examine the engraftment rate in patients receiving in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donors. * To evaluate th...
Detailed Description
This study is a single-arm, non-randomized feasibility study. Patients meeting the criteria for this study will be entered sequentially until completion or closure of the study. Early stopping rules w...
Eligibility Criteria
Inclusion
- Patients with hematologic malignancies or bone marrow failure syndrome who are candidates for allogeneic bone marrow transplantation are eligible for this study. Hematologic malignancies indicated for transplantation:
- Acute lymphoblastic leukemia (ALL) in first remission (with high risk feature), 2nd or greater remission.
- Acute myeloid leukemia (AML) in first remission (with high risk feature), 2nd or greater remission.
- Chronic myeloid leukemia (CML) in 2nd chronic phase or accelerated phase.
- Juvenile myelomonocytic leukemia (JMML).
- Myelodysplastic syndrome.
- Biphenotypic leukemia in first (with high risk feature), 2nd or greater remission.
- Induction failure leukemia.
- Refractory relapsed leukemia.
- Bone marrow failure syndrome.
- Severe aplastic anemia failed immunotherapy.
- Patients who do not have a 6 out of 6 matched related or unrelated donor or 4/6 and 5/6 matched cord blood will be eligible for this study.
- Partially mismatched related donor availability as defined by molecular typing with 3 to 5 HLA matches.
- Patients who are under 22 years of age.
Exclusion
- Patients will not be excluded based on sex, racial, or ethnic background.
- Patients will be excluded if they demonstrate significant functional deficits in major organs, which would obviously interfere with successful outcome following bone marrow transplant utilizing the following guidelines.
- Evidence of active, deep-seated, life-threatening infections for which there is no known effective therapy (certain fungal species, HIV, etc.).
- Patients who have been treated for infections must have appropriate responses as documented by 2 (two) consecutive negative cultures and/or stable radiographic examinations.
- Patients who have active central nervous system (CNS) leukemic disease.
- Patients will be excluded if they are women of childbearing potential who are currently pregnant (beta-HCG+) or who are not practicing adequate contraception.
- Patients who have had a previous hematopoietic stem cell transplant will be excluded.
- Donors will be excluded if they are sensitive to E. coli-derived protein.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00228813
Start Date
April 1 2004
End Date
January 1 2015
Last Update
September 11 2017
Active Locations (1)
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1
Children's Healthcare of Atlanta/Emory University
Atlanta, Georgia, United States, 30322