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

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ClinicalTrials.gov Identifier: NCT02258490
Expanded Access Status : Available
First Posted : October 7, 2014
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Edmund Waller, Emory University

Brief Summary:
Allogeneic hematopoietic stem cell transplantation (HSCT) is an established form of treatment for hematological abnormalities. Poor graft function, occurs when there poor donor engraftment. A second infusion of unselected donor hematopoietic stem cells (HSC) can result in improvement, but can potentially increase the incidence of graft versus host disease. Cluster of differentiation 34+ (CD34+) selected stem cells depleted of T-cells is an attractive alternative for treatment of poor graft function as it may be associated with less Graft versus Host Disease (GVHD) and enhanced count recovery. The investigators are using the Miltenyi CliniMACS device and CD34 cell selection reagents for the preparation of allogeneic hematopoietic progenitor cell (HPC) transplants for patients who have had prior stem cell transplants and require a stem cell "boost" from the original donor.

Condition or disease Intervention/treatment
Chronic Myeloid Leukemia Myelodysplastic Syndrome Acute Myeloid Leukemia Biological: G-CSF mobilized CD34+ selected cells for transplantation

Detailed Description:
This is a single-arm, open label, single institution, compassionate study which will enroll patients who are marginally engrafted and transfusion and/or growth factors dependent after allogeneic hematopoietic stem cell transplant (HSCT) regardless of the underlying disease for which the transplant was performed. Study subjects will receive a "booster" infusion of CD34+ cell selected and T-cell depleted G-CSF mobilized apheresis product from the original stem cell donor in order to improve engraftment. The "booster" infusion will be administered without prior conditioning.

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Study Type : Expanded Access
Official Title: Expanded Use of G-CSF Mobilized Donor CD34+ Selected Cells for Allogeneic Transplantation to Recipients With Limited Donor Engraftment



Intervention Details:
  • Biological: G-CSF mobilized CD34+ selected cells for transplantation

    Mobilization of Donor: Following screening and enrollment after informed consent, the donor will receive mobilization therapy with G-CSF (10 ug/Kg S/C daily x5-6 days) using the standard National Marrow Donor Program (NMDP) guidelines.

    CD34+ selection with CliniMACS device: CD34+ cell selection will be performed according to procedures given in the CliniMACS Users Operating Manual and institutional Standard Operating Procedures (SOPs). If the donor's plasma is not available, CliniMACS buffer will be used.

    The Day of CD34+ cell infusion: Immediately after the release tests have been performed and the product passes the release criteria, the patient will receive the final product. No conditioning regimen will be administered prior to cell infusion.


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258490


Contacts
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Contact: Edmund Waller, MD, PhD 404-778-6547 ewaller@emory.edu

Locations
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United States, Georgia
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Contact: Shantoria J. Mayes, MHA    404-778-6547    shantoria.mayes@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Edmund Waller, MD, PhD Emory University

Publications:

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Responsible Party: Edmund Waller, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT02258490     History of Changes
Other Study ID Numbers: IRB00051037
EPIC-HPC001 ( Other Identifier: Winship Cancer Institute )
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Keywords provided by Edmund Waller, Emory University:
chronic myeloid leukemia
myelodysplastic syndrome
acute myeloid leukemia
CD34+ cell mobilization therapy
graft versus host disease
allogeneic hematopoietic stem cell
G-CSF
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Myeloproliferative Disorders
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs