EUCTR2013-003421-28-DEActive, not recruitingPhase 1
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 enrollmentStarted: January 3, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 56
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •<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
- •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
- •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
- •Participation in another clinical trial (investigational drug therapy outside of this trial) during or within 4 weeks before study entry
Investigators
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