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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2018-09-30

Brief Summary

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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)

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Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Cytarabine

Intervention Type DRUG

Cytarabine 500-1000 mg/m2 bid IV infusion on D-4, -3, -2

Nivolumab

Intervention Type DRUG

Nivolumab 40 mg IV infusion on D+5

G-CSF mobilized HLA-haploidentical donor PBSC

Intervention Type BIOLOGICAL

G-CSF mobilized HLA-haploidentical donor peripheral blood stem cells IV infusion on D0

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

Group Type EXPERIMENTAL

Cytarabine

Intervention Type DRUG

Cytarabine 500-1000 mg/m2 bid IV infusion on D+1, +2, +3

Nivolumab

Intervention Type DRUG

Nivolumab 40 mg IV infusion on D+1

Interventions

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Cytarabine

Cytarabine 500-1000 mg/m2 bid IV infusion on D-4, -3, -2

Intervention Type DRUG

Nivolumab

Nivolumab 40 mg IV infusion on D+5

Intervention Type DRUG

Cytarabine

Cytarabine 500-1000 mg/m2 bid IV infusion on D+1, +2, +3

Intervention Type DRUG

Nivolumab

Nivolumab 40 mg IV infusion on D+1

Intervention Type DRUG

G-CSF mobilized HLA-haploidentical donor PBSC

G-CSF mobilized HLA-haploidentical donor peripheral blood stem cells IV infusion on D0

Intervention Type BIOLOGICAL

Other Intervention Names

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Ara-C Opdivo Ara-C Opdivo

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No