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

University of Minnesota (UMN)

Status and phase: Completed; Phase 2

Conditions: Acute Myelogenous Leukemia

Treatments: Biological: IL-15

Study type: Interventional

Funder types: Other

Identifiers

NCT02395822

2014LS092

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Preparative Regimen and SubQ rHuIL-15

Experimental group

Description:

Preparative Regimen of Fludarabine and Cyclophosphamide IL-15 Activation of Donor NK Cells: IL-15 to Facilitate NK Cell Survival and Expansion

Treatment:

Biological: IL-15