Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia
NCT ID: NCT00274846
Last Updated: 2017-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
21 participants
INTERVENTIONAL
2005-03-31
2008-06-30
Brief Summary
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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
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intent-to-Treat
All patients treated with natural killer (NK) cells (at a dose of 1.5-8 x 10\^7/kg.)
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
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
cyclophosphamide
Days -5 and -4: 60 mg/kg
fludarabine phosphate
Days -5 through -2: 25 mg/m\^2
in vitro treated peripheral blood stem cell transplantation
Day 0 infuse natural killer cells
Interventions
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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
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
cyclophosphamide
Days -5 and -4: 60 mg/kg
fludarabine phosphate
Days -5 through -2: 25 mg/m\^2
in vitro treated peripheral blood stem cell transplantation
Day 0 infuse natural killer cells
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
2 Years
ALL
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Miller, MD
Role: STUDY_CHAIR
Masonic Cancer Center, University of Minnesota
Locations
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Masonic Cancer Center
Minneapolis, Minnesota, United States
Countries
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References
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Bachanova V, Cooley S, Defor TE, Verneris MR, Zhang B, McKenna DH, Curtsinger J, Panoskaltsis-Mortari A, Lewis D, Hippen K, McGlave P, Weisdorf DJ, Blazar BR, Miller JS. Clearance of acute myeloid leukemia by haploidentical natural killer cells is improved using IL-2 diphtheria toxin fusion protein. Blood. 2014 Jun 19;123(25):3855-63. doi: 10.1182/blood-2013-10-532531. Epub 2014 Apr 9.
Other Identifiers
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UMN-2004LS073
Identifier Type: OTHER
Identifier Source: secondary_id
UMN-MT2004-25
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000450852
Identifier Type: -
Identifier Source: org_study_id