Status:
COMPLETED
Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Leukemia
Eligibility:
All Genders
2+ years
Phase:
PHASE2
Brief 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 ste...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00274846
Start Date
March 1 2005
End Date
June 1 2008
Last Update
December 28 2017
Active Locations (1)
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1
Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455