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

Technische Universität Dresden

Status and phase: Terminated; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Cytarabine; Biological: NK cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02229266

TUD-HINKL1-059

Details and patient eligibility

About

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

Full description

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

Enrollment: 1 patient

Sex: All

Ages: 60 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1 participants in 2 patient groups

NK cells

Experimental group

Description:

Infusion of haploidentical NK cells after immunosuppression with cyclophosphamide and fludarabine, followed by immunostimulatory treatment with interleukin-2

Treatment:

Biological: NK cells

Control Intervention

Active Comparator group

Description:

1 cycle of consolidation chemotherapy with high-dose cytarabine

Treatment:

Drug: Cytarabine