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MT2014-25: Haplo NK With SQ IL-15 in Adult Relapsed or Refractory AML Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02395822
Recruitment Status : Completed
First Posted : March 24, 2015
Results First Posted : January 10, 2018
Last Update Posted : February 20, 2018
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Brief Summary:
A phase II trial of CD3/CD19 depleted, IL-15 activated, donor natural killer (NK) cells in adults and subcutaneous IL-15 given after a preparative regimen for the treatment of relapsed or refractory acute myelogenous leukemia (AML). The primary objective is to study the potential efficacy of NK cells and IL-15 to achieve complete remission while maintaining safety.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Biological: IL-15 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MT2014-25: Haploidentical Donor Natural Killer (NK) Cell Infusion With Subcutaneous Recombinant Human IL-15 (rhIL-15) in Adults With Refractory or Relapsed Acute Myelogenous Leukemia (AML)
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Arm Intervention/treatment
Experimental: Preparative Regimen and SubQ rHuIL-15

Preparative Regimen of Fludarabine and Cyclophosphamide

IL-15 Activation of Donor NK Cells:

IL-15 to Facilitate NK Cell Survival and Expansion

Biological: IL-15

Preparative Regimen:

Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if < 4 months from prior transplant, omit day -4 dose)

IL-15 Activated Donor NK Cells:

The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.

IL-15 to Facilitate NK Cell Survival and Expansion:

IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total

Other Name: Interleukin-15

Primary Outcome Measures :
  1. < 5% Marrow Blast, no Circulating Peripheral Blasts and Neutrophil Count of > 1 x 10^9/L [ Time Frame: Day 42 post NK cell infusion ]
    Without platelet recovery

Secondary Outcome Measures :
  1. In Vivo Expansion (>100) of NK Cells (Defined at CD56+/CD3- Lymphocytes) [ Time Frame: Day 14 post NK cell infusion ]
  2. Proportion of Patients Experiencing Grade, 3, 4, and 5 Toxicities (Assessed by CTCAE v. 4) [ Time Frame: Days 1-5 and Days 8-12, 24 hours after the last IL-15 dose, Day +28, Day +42 ]
  3. Treatment Related Mortality [ Time Frame: 6 months post-therapy ]
  4. Number of Subjects Achieving Complete Response, Defined as in Vivo Donor Derived NK Cell Expansion of > 100 Donor Derived NK Cells. [ Time Frame: Day 42 post NK cell infusion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria (Recipient):

  • Meets ONE of the following disease criteria:

    1. Primary AML induction failure: no CR after 2 or more induction attempts
    2. Relapsed AML or Secondary AML (from MDS or treatment related): not in CR after 1 or more cycles of standard re-induction therapy
    3. AML relapsed > 2 months after transplant: No re-induction required, and no more than 1 re-induction cycle is allowed.
    4. Relapsed AML for patients > 60 years of age the 1 cycle of standard chemotherapy is not required if either of the following criteria is met:

      • Relapse within 6 months of last chemotherapy
      • BM blast count < 30% within 10 days of starting protocol therapy
  • Available related HLA-haploidentical donor (aged 14 to 75 years) by at least Class I serologic typing at the A&B locus
  • Karnofsky Performance Status ≥ 60%
  • Patients must have adequate organ within 14 days (28 days for pulmonary and cardiac) of study registration
  • Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to NK cell infusion (excluding preparative regimen pre-medications).
  • Agrees to use contraception prior to study entry and for the duration of study participation.

Exclusion Criteria (Recipient):

  • Bi-phenotypic acute leukemia.
  • Transplant < 60 days prior to study enrollment.
  • Active autoimmune disease.
  • History of severe asthma
  • Uncontrolled intercurrent illness
  • New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that has not been evaluated with bronchoscopy
  • Pleural effusion large enough to be detectable on chest x-ray.
  • Pregnant women
  • History of HIV, active or chronic hepatitis B, hepatitis C or HTLV-I infection
  • Known hypersensitivity to any of the study agents used
  • Received investigational drugs within the 14 days of study registration.
  • Known active CNS involvement.

Criteria For Initial Donor Selection:

  • Related donors (sibling, parent, offspring, parent or offspring of an HLA identical sibling).
  • 14-75 years of age.
  • At least 40 kilogram body weight.
  • In general good health as determined by the evaluating medical provider.
  • HLA-haploidentical donor/recipient match by at least Class I serologic typing at the A&B locus.
  • Not pregnant.
  • Able and willing to undergo apheresis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02395822

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United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
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Principal Investigator: Jeffrey Miller, MD Masonic Cancer Center, University of Minnesota
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Masonic Cancer Center, University of Minnesota Identifier: NCT02395822    
Other Study ID Numbers: 2014LS092
First Posted: March 24, 2015    Key Record Dates
Results First Posted: January 10, 2018
Last Update Posted: February 20, 2018
Last Verified: December 2017
Keywords provided by Masonic Cancer Center, University of Minnesota:
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type