Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML

Phase 2

Terminated

• Conditions: Acute Myeloid Leukemia
• Interventions: Biological: NK cells; Drug: Cytarabine

• Registration Number: NCT02229266
• Lead Sponsor: Technische Universität Dresden

Brief Summary

The trial investigates the efficacy of adoptive immunotherapy with haploidentical natural killer cells compared to standard chemotherapy (after first complete remission) in patients with a high-risk acute myeloid leukemia being older than 65 years of age and not eligible for allogeneic transplantation

Detailed Description

Randomised controlled phase-2 trial to determine the efficacy of adoptive immunotherapy with haploidentical natural killer cells in high-risk acute myeloid leukemia

Study Timeline

• Study First Submitted: 2014-08-28
• Study First Submitted QC: 2014-08-29
• Study First Posted: 2014-09-01
• Study Start: 2015-09
• Primary Completion: 2017-04-22
• Study Completion: 2017-04-22
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-10
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria
• In AML defined by cytogenetic aberrations the proportion of blasts may be <20%
• Age ≥60 years
• Clinical performance corresponding to ECOG score 0-2
• High-risk karyotype
• <5% myeloblasts in bone marrow ≥21 days after beginning of most recent chemotherapy
• maximal two preceding chemotherapy cycles
• Potentially available haploidentical family donor (child/ sibling), willing and fit for NK cell donation

Exclusion Criteria

• AML with favorable or intermediate risk cytogenetic features
• Persistent aplasia following preceding chemotherapy
• Relapsed or refractory AML
• Known pre-existing autoimmune diseases
• Any severe concomitant condition which makes it undesirable for the patient to participate in the study
• Any condition which could jeorpadize compliance of the protocol
• Participation in another clinical trial during or within 4 weeks before study entry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NK cells	NK cells	Infusion of haploidentical NK cells after immunosuppression with cyclophosphamide and fludarabine, followed by immunostimulatory treatment with interleukin-2
Control Intervention	Cytarabine	1 cycle of consolidation chemotherapy with high-dose cytarabine

Primary Outcome Measures

Name	Time	Method
2-year overall survival	2 years after study inclusion	measure time of survival of each patiente up to 2 years after study inclusion

Secondary Outcome Measures

Name	Time	Method
Time to relapse	2 years after study inclusion	evaluate time to relapse for 2 years after study inclusion for each patient; calculate cumulative incidence of relapse
Relapse-free survival	2 years after study inclusion
Yield and purity of NK cells (CD3-CD56+) after CD3 depletion and CD56 enrichment	timepoint of application of NK cells
NK cell analysis	2 years after study inclusion
Clinical performance (ECOG score)	2 years after study inclusion
Incidence and severity of GVHD	6 months after start of treatment
Incidence of (S)AEs	5 weeks after start of treatment

Trial Locations

Locations (3)

Universitätsklinikum Dresden; 🇩🇪 Dresden, Germany

Klinikum Bayreuth; 🇩🇪 Bayreuth, Germany

Klinikum Chemnitz; 🇩🇪 Chemnitz, Germany