Leukemia Clinical Trial
Official title:
Allogeneic Natural Killer Cells in Patients With Relapsed Acute Myelogenous Leukemia
Verified date | December 2017 |
Source | Masonic Cancer Center, University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria: - Primary refractory disease (no complete response [CR] after = 2 induction therapies) - Relapsed disease not in CR after = 1 course of standard reinduction therapy - Secondary AML from myelodysplastic syndromes - Disease relapsed = 2 months after transplant and no option of donor lymphocyte infusions (e.g., recipients of autologous or umbilical cord blood transplants) - Chronic myelogenous leukemia with myeloid blast crisis not in second chronic phase after at least one cycle of standard chemotherapy and imatinib - Over 60 years of age with relapse within 6 months after completion of last chemotherapy - Over 60 years of age with blast count < 30% within 10 days before study entry - Related HLA-haploidentical natural killer cell donor available - No severe organ damage (by clinical or laboratory assessment) - Performance status 50-100% - No evidence of active infection on chest X-ray - No active fungal infection Exclusion Criteria: - Active central nervous system (CNS) leukemia - Pleural effusions large enough to be detectable by chest x-ray - Pregnant or nursing (positive pregnancy test) - Fertile patients must use effective contraception - Less than 60 days since prior transplant - Less than 3 days since prior prednisone - Less than 3 days since other prior immunosuppressive medication |
Country | Name | City | State |
---|---|---|---|
United States | Masonic Cancer Center | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Masonic Cancer Center, University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients With Natural Killer (NK) Cell Expansion | 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). | Study Day 14 | |
Secondary | Number of Patients With Complete Remission | Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery). | Day 28-35 | |
Secondary | Median Time to Disease Relapse (Months) | 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. | From 1st Day of treatment until death or receipt of bone marrow transplant. | |
Secondary | Overall Survival Time of Patients With Complete Remission | Median number of months patients were alive after NK cell infusion. | From Day 1 of Treatment until death or patient received bone marrow transplant. | |
Secondary | Number of Patients With Complete Remission and Natural Killer Cell Expansion | Includes patients who had both a complete remission of disease and an expansion of natural killer cells. | Day 14 |
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