KIR Mismatched Haploidentical Donor Hematopoietic Progenitor Cell and Natural Killer Cell Transplantation With a TLI Based Conditioning Regimen in Patients With Hematologic Malignancies
N/A
21 Years
Both
Leukemia, Lymphoma
Trial Information
KIR Mismatched Haploidentical Donor Hematopoietic Progenitor Cell and Natural Killer Cell Transplantation With a TLI Based Conditioning Regimen in Patients With Hematologic Malignancies
Donors will undergo G-CSF mobilization of peripheral blood stem cells (PBSC) prior to
undergoing two apheresis collections of hematopoietic progenitor cells (HPC,A) and one
apheresis collection of therapeutic cell product of purified natural killer cells (TC-NK).
The HPC products will be T-cell depleted (TCD) using the investigational CliniMACS device.
CD34+ enrichment and CD45RA depletion will be utilized on sequential HPC grafts.
Participants will undergo a preparative regimen of total lymphoid irradiation, fludarabine,
cyclophosphamide, granulocyte colony stimulating factor (G-CSF), thiotepa, and melphalan.
This is followed by infusions of donor cells that have been prepared using the CliniMACS
system: HPC,A (CD34+ selected), HPC,A (CD45RA depleted), and TC-NK.
Inclusion Criteria
Inclusion Criteria - Transplant Recipients:
- Age less than or equal to 21 years.
- Does not have a suitable MSD or volunteer MUD available in the necessary time for
stem cell donation.
- Has a suitable single haplotype matched (≥ 3 of 6) and KIR-mismatched family member
donor.
- High risk hematologic malignancy. If prior CNS leukemia, it must be treated and in
CNS CR
- Does not have any other active malignancy other than the one for which this HCT is
indicated.
- No prior allogeneic HCT, and no autologous HCT within the previous 12 months.
- Patient must fulfill pre-transplant evaluation
Inclusion Criteria - Haploidentical Donor:
- At least single haplotype matched (≥ 3 of 6) family member
- KIR receptor-ligand mismatched to the recipient
- At least 18 years of age.
- HIV negative.
- Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days
prior to enrollment (if female).
- Not lactating.
- Regarding eligibility, is identified as either: (1) Completed the process of donor
eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR (2) Does
not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent
medical need completed by the principal investigator or physician sub-investigator
per 21 CFR 1271.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of successful engraftment
Outcome Description:
Neutrophil engraftment will be determined using the parameters put forth by the Center for International Blood and Marrow Registry. Assessments will be made upon review of daily complete blood count and serial chimerism studies. Successful engraftment for the purposes of this objective will be patients who do not experience graft failure.
Outcome Time Frame:
42 days post engraftment
Safety Issue:
No
Principal Investigator
Brandon M. Triplett, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Jude Children's Research Hospital
Authority:
United States: Food and Drug Administration
Study ID:
HAPNK1
NCT ID:
NCT01807611
Start Date:
April 2013
Completion Date:
April 2019
Related Keywords:
- Leukemia
- Lymphoma
- Haploidentical donor transplantation
- NK cell
- Leukemia
- Lymphoma
- Hematologic Neoplasms
Name | Location |
|---|---|
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
