At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of AML in remission or relapse (including FAB M7 or biphenotypic leukemia)
- ✓Diagnosis of high-risk ALL in first remission (e.g., poor responder to prednisone, Ph+ ALL)
- ✓Diagnosis of ALL beyond first remission
- ✓Diagnosis of secondary leukemia
- ✕Age greater than 24 months at time of transplant
- ✕HLA-identical sibling donor available
- ✕Cardiac dysfunction with shortening fraction <25%
- ✕Oxygen saturation <92% on room air by pulse oximetry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
HLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies
In Brief
A Phase 2 clinical trial evaluating Chemotherapy and antibodies, Miltenyi Biotec CliniMACS, and 1 other intervention for Acute Myeloid Leukemia and 4 related conditions. Completed, enrolled 40 participants across 1 site.
Detailed Summary
Recent studies of conventional chemotherapy for infants with high-risk hematologic malignancies show that the long-term disease-free survival is low. Although blood and marrow stem cell transplantation using an HLA identical sibling has improved the outcome for these children, less than 25% have this donor source available. Another option is haploidentical transplantation using a partially matched family member donor (i.e. parental donor). Although haploidentical transplantation has proven curative for some patients, this procedure has been hindered by significant complications, primarily regimen-related toxicity including infection and graft versus host disease (GVHD). Building on prior institutional trials, this study will provide patients a haploidentical graft depleted of T lymphocytes using the investigational device, CliniMACS selection system. One week after the transplant procedure, patients will also receive an infusion of additional donor derived white blood cells called Natural Killer (NK) cells in an effort to decrease risks for rejection of the graft, disease relapse, and regimen related toxicity. The primary objective of the study is to evaluate 1 year survival in infants with high risk hematologic malignancies who receive this study treatment.
Study Details
Timeline
Interventions
Study participants will receive a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants will receive an infusion of additional donor derived cells called NK cells.
Stem cell selection device
Allogeneic natural killer (NK)cell infusion