Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia
RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps 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.
PURPOSE: This clinical trial is studying how well a peripheral stem cell transplant using NK cells from a donor works in treating patients with relapsed acute myeloid leukemia.
Biological: therapeutic allogeneic lymphocytes
Drug: fludarabine phosphate
Procedure: in vitro treated peripheral blood stem cell transplantation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Allogeneic Natural Killer Cells in Patients With Relapsed Acute Myelogenous Leukemia|
- Number of Patients With Natural Killer (NK) Cell Expansion [ Time Frame: Study Day 14 ] [ Designated as safety issue: No ]Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (>100 donor-derived NK cells per uL of patient blood detectable at day +14).
- Number of Patients With Complete Remission [ Time Frame: Day 28-35 ] [ Designated as safety issue: No ]Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery).
- Median Time to Disease Relapse (Months) [ Time Frame: From 1st Day of treatment until death or receipt of bone marrow transplant. ] [ Designated as safety issue: No ]Follow-up continued every 3 months after the allogeneic natural killer (NK) cell infusion, unless they were transplanted, relapsed or had progressive disease. Time in months to relapse of disease is calculcated from 1st day of treatment with NK cells. Relapse occurs when leukemia is detected in bone marrow or blood.
- Overall Survival Time of Patients With Complete Remission [ Time Frame: From Day 1 of Treatment until death or patient received bone marrow transplant. ] [ Designated as safety issue: No ]Median number of months patients were alive after NK cell infusion.
- Number of Patients With Complete Remission and Natural Killer Cell Expansion [ Time Frame: Day 14 ] [ Designated as safety issue: No ]Includes patients who had both a complete remission of disease and an expansion of natural killer cells.
|Study Start Date:||March 2005|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
All patients treated with natural killer (NK) cells (at a dose of 1.5-8 x 10^7/kg.)
10 million units three times a week for a total of 6 doses. For any subject less than 45 kilograms the IL-2 will be given at 5 million units per meter squared three times weekly for a total of 6 doses
Other Name: IL-2Biological: therapeutic allogeneic lymphocytes
Cells infused per kg. 1.5-8.0 x 10^7/kg Total cells infused(for 70 kg. adult) 1.05 - 5.6 x 10^9
Other Name: lymphocytesDrug: cyclophosphamide
Days -5 and -4: 60 mg/kg
Other Name: CytoxanDrug: fludarabine phosphate
Days -5 through -2: 25 mg/m^2
Other Name: FludaraProcedure: in vitro treated peripheral blood stem cell transplantation
Day 0 infuse natural killer cells
Other Name: Natural Killer Cells
- Evaluate the in vivo expansion of natural killer (NK) cells 14 days after treatment with allogeneic NK cell-enriched peripheral blood stem cell transplantation in patients with relapsed acute myeloid leukemia.
- Determine the response rate, in terms of complete remission, in patients treated with this regimen.
- Correlate complete remission rate with NK cell expansion, interleukin-15 levels, and donor/recipient killer immunoglobulin receptor (KIR) ligand matching status in patients treated with this regimen.
- Determine the overall and progression-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is an open-label study.
- Induction therapy: Patients receive fludarabine IV on days -6 to -2 and cyclophosphamide IV on day -5 or on days -5 and -4.
- Allogeneic natural killer (NK) cell-enriched peripheral blood stem cell transplantation: Patients receive allogeneic NK cell-enriched peripheral blood stem cells IV over 15-60 minutes on day 0. Patients also receive interleukin-2 subcutaneously beginning on day 0 and continuing 3 times a week for up to 2 weeks.
After completion of study treatment, patients are followed periodically for 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274846
|United States, Minnesota|
|Masonic Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|Study Chair:||Jeffrey Miller, MD||Masonic Cancer Center, University of Minnesota|