Newly diagnosed high-risk AML other than acute promyelocytic leukemia, =20% blasts MedDRA version: 17.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864
Conditions
Interventions
Product Name: CD3-negative/ CD56-positive NK cells from HLA-haploidentical family donors
Pharmaceutical Form: Infusion
Sponsors
Technische Universität Dreden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria, i.e. bone marrow aspirate or biopsy must have contained =20% blasts • Clinical performance corresponding to ECOG score 0-2 • High-risk karyotype • 1.5 GPT/l; neutrophil granulocytes >0.5 GPT/l) • No available HLA-matched (= 9 of 10 HLA-alleles) stem cell donor or unfit for allogeneic hematopoietic stem cell transplantation • Available haploidentical family donor, willing and fit for NK cell donation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 56 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 56
Exclusion criteria
Exclusion criteria: • AML with favorable risk cytogenetic features, i.e. t(15;17) or PML-RAR alpha transcript or t(8;21) or RUNX1 transcript or inv(16) or CBFa transcript • AML with t(9;11)(p22;q23) • AML with intermediate risk cytogenetic features, i.e. no high-risk cytogenetic features as defined in inclusion criteria and no favorable cyto-genetic features as defined in exclusion criteria, FLT3-ITD ratio =0.8 • Persistent aplasia following preceding chemotherapy • Relapsed or refractory AML • Available HLA-matched (=9 of 10 HLA-alleles) stem cell donor and patient fit for allogeneic stem cell transplantation • Age °2 ) • Any condition which could jeorpadize compliance of the protocol • Participation in another clinical trial (investigational drug therapy outside of this trial) during or within 4 weeks before study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of haploidentical NK-cell based consolidation with standard cytarabine based consolidation in elderly patients suffering from AML with high risk of fatal relapse and no option for allogeneic stem cell transplantation (SCT). ;Secondary Objective: - To compare the time to relapse (TTR), the cumulative incidence of relapse (CIR) and relapse-free survival (RFS) between the two study groups - To investigate the yield and purity of NK cells (CD3-CD56+) after CD3 de-pletion and CD56 enrichment - To investigate patients NC cell recovery, NK cell chimerism, NK phenotype and functional capacity of NK cells at various time points after infusion - To compare tolerability and safety of the two interventions;Primary end point(s): 2-year overall survival;Timepoint(s) of evaluation of this end point: 2-year after study inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to relapse (TTR), cumulative incidence of relapse (CIR), • Relapse-free survival (RFS), • Yield and purity of NK cells (CD3-CD56+) after CD3 depletion and CD56 enrichment, • Patient NK cell recovery • NK cell chimerism • NK phenotype s • Clinical performance (ECOG score) • Incidence and severity of GVHD • Incidence of AEs and SAEs;Timepoint(s) of evaluation of this end point: up to 2 years from study inclusion | — |
Countries
Germany
Contacts
Public ContactMedizinische Klinik I
Universitätsklinikum Dresden
Outcome results
None listed