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

Acute Myeloid Leukemia Clinical Trial

— HINKL  

Official title:

Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With Haploidentical Natural Killer Cells in High-risk Acute Myeloid Leukemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02229266
• Other study ID #: TUD-HINKL1-059
• Status: Terminated
• Phase: Phase 2
• Start date: September 2015
• Est. completion date: April 22, 2017

Study information

• Verified date: August 2021
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 22, 2017
• Est. primary completion date: April 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• NK cells

Drug:
• Cytarabine
1 cycle of consolidation chemotherapy with high-dose cytarabine

Locations

Country	Name	City	State
Germany	Klinikum Bayreuth	Bayreuth
Germany	Klinikum Chemnitz	Chemnitz
Germany	Universitätsklinikum Dresden	Dresden

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year overall survival	measure time of survival of each patiente up to 2 years after study inclusion	2 years after study inclusion
Secondary	Time to relapse	evaluate time to relapse for 2 years after study inclusion for each patient; calculate cumulative incidence of relapse	2 years after study inclusion
Secondary	Relapse-free survival		2 years after study inclusion
Secondary	Yield and purity of NK cells (CD3-CD56+) after CD3 depletion and CD56 enrichment		timepoint of application of NK cells
Secondary	NK cell analysis		2 years after study inclusion
Secondary	Clinical performance (ECOG score)		2 years after study inclusion
Secondary	Incidence and severity of GVHD		6 months after start of treatment
Secondary	Incidence of (S)AEs		5 weeks after start of treatment

External Links

•   Study Alliance Leukemia
•   Universitätsklinikum Dresden, Medizinische Klinik I