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

Stopped early · Not applicable

Conditions studied: Hematologic Malignancies

In brief

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 the incidence and severity of acute and chronic graft-versus-host disease in patients receiving in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donors.

Key facts

Study ID

NCT00228813

Run by

Emory University

People needed

8

Starts

2004-04-01

Expected to finish

2015-01-01

Last updated by the study team

2017-09-11

Who can join

Age: any, up to 22. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Healthcare of Atlanta/Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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