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KIR Mismatched Haploidentical Donor Hematopoietic Progenitor Cell and Natural Killer Cell Transplantation With a TLI Based Conditioning Regimen in Patients With Hematologic Malignancies


Phase 2
N/A
21 Years
Open (Enrolling)
Both
Leukemia, Lymphoma

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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