Haploidentical Lymphocytes With Nivolumab/Ara-C as Consolidation in Elderly AML Patients

St. Petersburg State Pavlov Medical University

Status and phase

Terminated

Phase 2

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Nivolumab

Drug: Cytarabine

Biological: G-CSF mobilized HLA-haploidentical donor PBSC

Study type

Interventional

Funder types

Other

Identifiers

NCT03381118

31/17-n

Details and patient eligibility

About

A phase II trial to compare the efficacy and safety of nivolumab and intermediate dose cytarabine with or without haploidentical lymphocyte infusion. To identify the role of haploidentical lymphocytes in the treatment of acute myeloid leukemia in older adults. The patients will be stratified based on the remission number (first or second)

Enrollment

16 patients

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with a diagnosis of acute myeloid leukemia with the confirmed first or second complete remission
≥ 55 years of age
Not candidates for allogeneic stem cell transplantation as decided by the panel of hematologists at the transplant center
Patients with a HLA-haploidentical donor who should be able to provide informed consent for peripheral blood apheresis
No severe concurrent illness that limits life expectancy to less than 2 years

Exclusion criteria

Uncontrolled bacterial or fungal infection at the time of enrollment
Karnofsky index <70%
Acute promyelocytic leukemia
Other tumor requiring treatment at the time of enrollment
Active or prior documented autoimmune disease requiring systemic treatment
Somatic or psychiatric disorder making the patient unable to sign informed consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

16 participants in 2 patient groups

Ara-C+HaploLymphocyte+Nivo

Experimental group

Description:

Patients treated with nivolumab, intermediate dose cytarabine and haploidentical lymphocyte infusion: \[Cytarabine 500-1000 mg/m2 bid D-4, -3, -2 + G-CSF mobilized HLA-haploidentical donor peripheral blood stem cells infusion D0 + Nivolumab 40 mg D+5\] х 2-3 cycles

Treatment:

Drug: Nivolumab

Biological: G-CSF mobilized HLA-haploidentical donor PBSC

Drug: Nivolumab

Drug: Cytarabine

Ara-C+ Nivo

Experimental group

Description:

Patients treated with nivolumab and intermediate dose cytarabine: \[Cytarabine 500-1000 mg/m2 bid D+1, +2, +3 + Nivolumab 40 mg D+1\] х 2-3 cycles

Treatment:

Drug: Nivolumab

Drug: Cytarabine