Status:
TERMINATED
Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
German Research Foundation
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60-99 years
Phase:
PHASE2
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 a...
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2017
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT02229266
Start Date
September 1 2015
End Date
April 22 2017
Last Update
August 16 2021
Active Locations (3)
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1
Klinikum Bayreuth
Bayreuth, Germany
2
Klinikum Chemnitz
Chemnitz, Germany
3
Universitätsklinikum Dresden
Dresden, Germany