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

Technische Universität Dreden0 sites56 target enrollmentJanuary 3, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ewly diagnosed high-risk AML other than acute promyelocytic leukemia, =20% blasts
Sponsor: Technische Universität Dreden
Enrollment: 56
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

January 3, 2014

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Technische Universität Dreden

•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
•\<5% myeloblasts in bone marrow \=21 days after beginning of most recent chemotherapy
•maximal two preceding chemotherapy cycles (either two induction cycles or one induction \+ one consolidation cycle)
•Study inclusion (experimental or control intervention) latest 56 days after preceding chemotherapy
•Reconstitution of peripheral blood leukocytes following chemotherapy (total leukocytes \>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

•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 \<60 years
•Known pre\-existing autoimmune diseases
•Any severe concomitant condition which makes it undesirable for the patient to participate in the study (e.g. end stage irreversible multi organ failure, HIV infection, uncontrolled active infections \>°2 )
•Any condition which could jeorpadize compliance of the protocol