Phase 2
N=21
Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00274846 ↗Enrolled (actual)
21
Serious AEs
90.5%
Results posted
Sep 2009
Primary outcome: Primary: Number of Patients With Natural Killer (NK) Cell Expansion — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- aldesleukin (Biological); therapeutic allogeneic lymphocytes (Biological); cyclophosphamide (Drug); fludarabine phosphate (Drug); in vitro treated peripheral blood stem cell transplantation (Procedure)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Natural Killer (NK) Cell Expansion |
2 | — |
| SECONDARY Number of Patients With Complete Remission |
2 | — |
| SECONDARY Median Time to Disease Relapse (Months) |
7.3 | — |
| SECONDARY Overall Survival Time of Patients With Complete Remission |
13 | — |
| SECONDARY Number of Patients With Complete Remission and Natural Killer Cell Expansion |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00274846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.