Trial record 21 of 292 for:    Expanded Access Studies

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

Expanded access is currently available for this treatment.
Verified October 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Edmund Waller, Emory University
ClinicalTrials.gov Identifier:
NCT02258490
First received: September 16, 2014
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

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.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 Intervention
Chronic Myeloid Leukemia
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Biological: G-CSF mobilized CD34+ selected cells for transplantation

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

Resource links provided by NLM:


Further study details as provided by Emory University:

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.

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.

  Eligibility

Ages Eligible for Study:   17 Years to 75 Years
Genders Eligible for Study:   Both
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 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/ul, absolute neutrophil count (ANC) < 500/ul 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02258490

Contacts
Contact: Edmund Waller, MD, PhD 404-778-3708 ewaller@emory.edu

Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Contact: Edmund Waller, MD, PhD    404-778-3708    ewaller@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Edmund Waller, MD, PhD Emory University
  More Information

Publications:

Responsible Party: Edmund Waller, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT02258490     History of Changes
Other Study ID Numbers: IRB00051037, EPIC-HPC001
Study First Received: September 16, 2014
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by 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:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Precancerous Conditions

ClinicalTrials.gov processed this record on March 26, 2015