At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Reduced Intensity Haploidentical Hematopoietic Stem Cell Transplantation (HSCT) Supplemented With Donor Natural Killer (NK) Cell Infusions in Patients With High Risk Myeloid Malignancies Who Are Unsuitable for Fully Myeloablative Transplantation
In Brief
A Phase 2 clinical trial evaluating aldesleukin, natural killer cells, and 6 other interventions for Acute Myelogenous Leukemia. Completed, enrolled 50 participants across 1 site.
Detailed Summary
RATIONALE: Giving chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total body irradiation, before peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer (NK) cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving IL-2 (aldesleukin) after NK cell infusion may stimulate them to kill any remaining cancer cells. PURPOSE: This phase I/II (currently enrolling in phase II) trial is studying how well a donor natural killer cell infusion works in treating patients who are undergoing donor stem cell transplant for acute myeloid leukemia.
Study Details
Timeline
Interventions
Administered subcutaneously (SQ) 9 million units every other day beginning Day -12 through -2 (evening of natural killer cell infusion) for a total of 6 doses.
Infusion given on Day -12; The targeted infused cell dose of CD3- CD19- selected NK product is within the range of 2-3 x 10\^7 cells/kg.
Administered intravenously (IV) 50 mg/kg on Day -15
Administered intravenously (IV) 40 mg/m\^2 on Days -18 through -14
On day 0, patients will receive an allogeneic transplant using pool cells from the day -1 and day 0 PBSC which will be CD34+ selected as the donor graft. The graft will be infused over 15-60 minutes.
Administered on Day -13, 200 cGy two times.
intravenous (IV) 3 mg/kg on Day 0 (day of donor CD34 cell infusion)
1.5 mg/kg by mouth or intravenously for target dose range of 150-250; day -15 through day -8.
Administered intravenously (IV) 50 mg/kg on Days -16 and -15
Administered intravenously (IV) 35 mg/m\^2 on Days -18 through -14