Phase 2 N=17 Treatment

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

Acute Myelogenous Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT02395822 ↗

Enrolled (actual)

Serious AEs

70.6%

Results posted

Jan 2018

Primary outcome: Primary: < 5% Marrow Blast, no Circulating Peripheral Blasts and Neutrophil Count of > 1 x 10^9/L — 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: IL-15 (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Masonic Cancer Center, University of Minnesota
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY < 5% Marrow Blast, no Circulating Peripheral Blasts and Neutrophil Count of > 1 x 10^9/L	5	—
SECONDARY In Vivo Expansion (>100) of NK Cells (Defined at CD56+/CD3- Lymphocytes)	4	—
SECONDARY Proportion of Patients Experiencing Grade, 3, 4, and 5 Toxicities (Assessed by CTCAE v. 4)	10	—
SECONDARY Treatment Related Mortality	2	—
SECONDARY Number of Subjects Achieving Complete Response, Defined as in Vivo Donor Derived NK Cell Expansion of > 100 Donor Derived NK Cells.	1	—

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.

Eligibility Criteria

Inclusion Criteria (Recipient):

Meets ONE of the following disease criteria:
Primary AML induction failure: no CR after 2 or more induction attempts
Relapsed AML or Secondary AML (from MDS or treatment related): not in CR after 1 or more cycles of standard re-induction therapy
AML relapsed > 2 months after transplant: No re-induction required, and no more than 1 re-induction cycle is allowed.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02395822). 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.