logo Hematology/Oncology Research Studies: Open for Enrollment Date: 10/22/18

Category: STEM CELL TRANSPLANTATION AND CELLULAR THERAPY

Role of KIR-favorably Mismatched Haploidentical Transplantation and KIR-polymorphisms in Determining Outcomes of Children with ALL/AML/MDS Undergoing Allogeneic Hematopoietic Cell Transplantation

NCT#/Phase: NCT02646839
Phase 1/2
IRB#: 2017-018
Description: This is an open-label, non-randomized, prospective study of haploidentical transplantation using KIR-favorable donors for children with acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT). This study includes a Biology arm for all AML/MDS/ALL patients undergoing a bone marrow transplant. In addition there is a therapeutic arm for patients with high risk AML/MDS/ALL who are receiving a KIR-favorable haploidentical transplant and will require graft depletion of T- cell receptor a-Beta+CD3+/CD19+cells prior to stem cell infusion. There is also an observational arm for patients who will require graft depletion of TCR a-Beta+CD3+/CD19+cells for none-KIR-favorable Haploidentical transplants.
Inclusion: Individuals who are < 22 years of age and who do not have a suitably HLA-matched related or unrelated donor available. Diseases include: ALL high-risk in first remission, ALL in second remission, Myelodysplastic syndrome, High-risk AML, AML in second or subsequent morphologic remission.
Enrollment Status: Open for enrollment
Sponsor: Pediatric Blood and Marrow Transplatn Consortium
Principal Investigator(s): Nahal Rose Lalefar, MD
Contact(s): Marci Moriarty, RN (510-428-3385 x5396)
Julie Decaris (510-428-3385 x2739)
Study Link: https://clinicaltrials.gov/ct2/show/NCT02646839

UCSF Benioff Children's Hospital Oakland • 747 52nd Street, Oakland, California 94609 &bull Phone: (510) 428-3000