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

February 28, 2022 updated by: Edmund Waller, Emory University

Expanded Use of G-CSF Mobilized Donor CD34+ Selected Cells for Allogeneic Transplantation to Recipients With Limited Donor Engraftment

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University/Winship Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 71 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Publications and helpful links

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General Publications

Study record dates

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Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00051037
  • EPIC-HPC001 (Other Identifier: Winship Cancer Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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