Expanded Use of G-CSF Mobilized Donor CD34+ Selected Cells for Allogeneic Transplantation

This is an expanded access trial for Chronic Myeloid Leukemia focused on measuring chronic myeloid leukemia, myelodysplastic syndrome, acute myeloid leukemia, CD34+ cell mobilization therapy, graft versus host disease, allogeneic hematopoietic stem cell, G-CSF Read More

Donor Inclusion Criteria:

• Donors must be eligible and approved for a hematopoietic stem cell graft according to institutional criteria (related donor) or NMDP criteria (volunteer unrelated donor)
• Donors must be ≥ 17 years old and ≤ 75 years old
• Donors must be agreeable to receive G-CSF for CD34 cell mobilization and undergo apheresis for the second donation of peripheral blood mononuclear cells (PBMC)
• Donor must have adequate peripheral venous catheter access for apheresis or must agree to placement of a central catheter

• The following laboratory tests/evaluations will be performed for all donors registered in the study. Additional evaluations/studies may also be performed by the site as dictated by the donor's clinical situation or standard practice for monitoring normal donors

  • History and physical examination
  • Automated complete blood count (WBC, red blood cells [RBC], hematocrit, hemoglobin) with differential and platelet counts
  • Serum chemistries panel including electrolytes, glucose, blood urea nitrogen (BUN), alanine aminotransferase (ALT), creatinine, bilirubin, alkaline phosphatase, lactate dehydrogenase (LDH) and albumin. Electrolytes to include sodium, potassium, chloride, carbon dioxide, calcium and magnesium.

  • Infections disease titers by FDA licensed tests for:

    • Cytomegalovirus (CMV) antibody
    • Hepatitis panel (Hepatitis B including HBsAg, HBcAb [immunoglobulin M {IgM} and immunoglobulin G {IgG}]; hepatitis C antibody)
    • HIV 1+2 antibodies
    • Hepatitis C virus (HCV) antibodies
    • Human T-lymphotropic virus (HTLV) I/II antibodies
    • Rapid plasmin reagin (RPR)
    • HIV-1 nucleic acid amplification test (NAT)
    • HCV NAT
    • West Nile virus (WNV)
    • These tests will be obtained, and reported to Emory, within 30 days prior to collection of the CD34+ cell product.

Recipient Inclusion Criteria:

• Only patients who are experiencing life-threatening hematological insufficiency, following an allogeneic hematopoietic stem cell transplant will be enrolled into this study
• Patient must be age > 17
• Must have ≥ 90% donor cells in the unfractionated peripheral blood based on either XY fluorescence in situ hybridization (FISH) or standard short tandem repeats (STR)
• More than 60 days post allogeneic stem cell transplantation and no reversible etiology found after an allogeneic stem cell transplantation

• Must meet one of the following criteria:

  • Platelets < 20,000/μl, absolute neutrophil count (ANC) < 500/μl or
  • Transfusion dependent for at least one cell line and/or
  • On growth factor support (G-CSF) without adequate response for 30 days
• The original HSCT donor must be available, willing, and medically able to undergo G-CSF mobilization and the apheresis procedures
• Patients must have non-immune mediated graft dysfunction