Status:
COMPLETED
Haploidentical Donor Hematopoietic Progenitor Cell and NK Cell Transplantation for Hematologic Malignancy
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Assisi Foundation
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief Summary
In this study, participants with high-risk hematologic malignancies undergoing hematopoietic cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA) matched related/siblin...
Detailed Description
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 the...
Eligibility Criteria
Inclusion
- 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 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
- 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 breast feeding.
- 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.
Exclusion
Key Trial Info
Start Date :
May 16 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2021
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01807611
Start Date
May 16 2013
End Date
September 27 2021
Last Update
October 31 2022
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105