Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02158767
Expanded Access Status : Available
First Posted : June 9, 2014
Last Update Posted : August 19, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paolo Caimi, MD, Case Comprehensive Cancer Center

Brief Summary:

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").


Condition or disease Intervention/treatment
Hematopoietic/Lymphoid Cancer Biological: Allogenic T cell-depleted hematopoietic stem cell transplantation

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.


Layout table for study information
Study Type : Expanded Access
Official Title: Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: Allogenic T cell-depleted hematopoietic stem cell transplantation
    Undergo CD34+ enriched T-cell depleted allogeneic peripheral blood stem cell transplant. T-cells will be removed using the experimental CliniMACS(r) Reagent System used in vitro to select and enrich CD34+ cells

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02158767


Contacts
Layout table for location contacts
Contact: Paolo Caimi, MD 216-844-8220 paolo.caimi@uhhospitals.org

Locations
Layout table for location information
United States, Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Contact: Paolo F. Caimi    216-844-8220    paolo.caimi@case.edu   
Principal Investigator: Paolo F. Caimi         
Sponsors and Collaborators
Paolo Caimi, MD
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Paolo Caimi Case Comprehensive Cancer Center

Layout table for additonal information
Responsible Party: Paolo Caimi, MD, Principal Investigator, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02158767     History of Changes
Other Study ID Numbers: CASE16Z13
NCI-2013-02383 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE16Z13 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: June 9, 2014    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019