NCT00274846

Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia

Allogeneic Natural Killer Cells in Patients With Relapsed Acute Myelogenous Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	aldesleukin	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
BIOLOGICAL	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
DRUG	cyclophosphamide	Days -5 and -4: 60 mg/kg
DRUG	fludarabine phosphate	Days -5 through -2: 25 mg/m\^2
PROCEDURE	in vitro treated peripheral blood stem cell transplantation	Day 0 infuse natural killer cells

Timeline

• Start date: 2005-03-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-01-11
• Last updated: 2017-12-28
• Results posted: 2009-09-07

Locations

1 site across 1 country: United States