- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02158767
Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.
This clinical trial studies the use of a second infusion of donor hematopoietic cells that have had removal of T cells for the treatment of engraftment failure after a first hematopoietic stem cell transplant.
Hematopoietic cell transplants from donors can be complicated by complete or incomplete failure of recovery of blood counts. This results in frequent needs for transfusions and other methods to maintain blood counts at acceptable levels. One way of improving the blood counts in the recipient is to give a "booster" dose of cells from the donor, but this is associated with increased risk of an immune reaction from the donor cells against the recipient cells. To decrease this risk, it is possible to decrease the amount of T cells, responsible for this type of immune reaction. These cells are removed by a special handling of the graft, which allows to remove the cells directly or indirectly (by selecting other cells to "stay" in the graft").
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To provide patients with suboptimal engraftment after allogeneic stem cell transplantation access to donor - derived, cluster of differentiation (CD34)+ enriched or T-cell depleted peripheral blood stem cells isolated by the CliniMACS System.
OUTLINE:
Patients undergo CD34+ enriched or T-cell depleted peripheral blood stem cell infusion (PBSCT) over 1-3 hours.
After completion of study treatment, patients are followed up for 100 days.
Study Type
Contacts and Locations
Study Contact
- Name: Leland Metheny, MD
- Phone Number: 1-800-641-2422
- Email: CTUReferral@UHhospitals.org
Study Locations
-
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Ohio
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Cleveland, Ohio, United States, 44106-5065
- Available
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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Contact:
- Leland Metheny, MD
- Phone Number: 800-641-2422
- Email: CTUReferral@UHhospitals.org
-
Principal Investigator:
- Leland Metheny, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who received a prior hematopoietic progenitor cell transplantation, including matched sibling and unrelated donor transplants, mismatched sibling and unrelated donor transplants and haploidentical transplants from related donors
- Patients with a presence of secondary engraftment failure defined as decrease in donor chimerism by ≥ 50% (i.e. 40% to 20%) in two measurements done at least 30 days apart
OR a presence of incomplete graft function manifested by presence of persistent or new cytopenias 60 or more days after transplantation:
- Anemia; hemoglobin less than 8g/dL, or red blood cell transfusion requirements over the preceding 4 weeks
- Neutropenia, with absolute neutrophil count less than 1,000 neutrophils per microliter or requirement of growth factor support over the preceding 4 weeks
- Thrombocytopenia, with platelet counts below 20,000 platelets per microliter or platelet transfusion requirements over the preceding 4 weeks
Exclusion Criteria:
- Patients for whom hematopoietic progenitor cells from the original donor are not available
Presence of reversible causes of engraftment failure or incomplete graft function, including
- Active viral infection
- Medications
- Acute or chronic graft versus host disease (GVHD) that is not controlled to less or equal than stage II with immunosuppressants
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leland Metheny, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CASE16Z13
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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