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

Sponsor
St. Petersburg State Pavlov Medical University
Study ID
NCT03381118
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Cytarabine — DRUG
    Cytarabine 500-1000 mg/m2 bid IV infusion on D-4, -3, -2
  • Nivolumab — DRUG
    Nivolumab 40 mg IV infusion on D+5
  • Cytarabine — DRUG
    Cytarabine 500-1000 mg/m2 bid IV infusion on D+1, +2, +3
  • Nivolumab — DRUG
    Nivolumab 40 mg IV infusion on D+1
  • G-CSF mobilized HLA-haploidentical donor PBSC — BIOLOGICAL
    G-CSF mobilized HLA-haploidentical donor peripheral blood stem cells IV infusion on D0

Study Details

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)

Key Dates

Start date
Jun 30, 2017
Status verified
Apr 2019
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ara-C+HaploLymphocyte+Nivo
    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
  • Experimental: Ara-C+ Nivo
    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

Primary Outcome Measure

Disease-free survival [ Time Frame: 2 years ]

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