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MT2014-25: Haplo NK With SQ IL-15 in Adult Relapsed or Refractory AML Patients | Clinical Trials | Clareo Health

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

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)

NCT02395822•Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+2 more criteria

Exclusion Criteria

•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
+10 more criteria

Locations (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

October 1, 2015

Primary Completion Date

December 1, 2016

Completion Date

December 1, 2016

Last Updated

February 20, 2018

Enrollment

ACTUAL participants

Conditions

Acute Myelogenous Leukemia

Interventions

IL-15

BIOLOGICAL

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

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AML (Acute Myelogenous Leukemia)Acute Lymphoid Leukemia (ALL)+9 more

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RECRUITING

Correlation of Venetoclax Plasma Concentrations With Toxicity of Hypometilating Agents and Venetoclax Combination for Acute Myeloid Leukemia Patients in Remission.

NCT07254312

AML (Acute Myelogenous Leukemia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

Correlation of Venetoclax Plasma Concentrations With Toxicity of Hypometilating Agents and Venetoclax Combination for Acute Myeloid Leukemia Patients in Remission.

HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy

Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCT

Phase I Trial of the Selective Inhibitor of Nuclear Export, KPT-330, in Relapsed Childhood ALL and AML

PRO#1278: Fludarabine and Busulfan vs. Fludarabine, Busulfan and Total Body Irradiation