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

• Status: Terminated
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Lenograstim; Sargramostim

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.