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

Phase 2TerminatedNCT03381118

St. Petersburg State Pavlov Medical University16 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia

Interventions

CytarabineDRUG

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

NivolumabDRUG

Nivolumab 40 mg IV infusion on D+5

CytarabineDRUG

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

Nivolumab

Eligibility

Sex: ALLMin age: 55 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Boris V Afanasyev, MD, Prof.

Saint Petersburg, Russia

Outcomes

Primary Outcomes

Disease-free survival

DFS will be assessed with Kaplan-Meier method from the date of last remission before randomization until the date of relapse or the date of death

Time frame: 2 years

Secondary Outcomes

Overall survival

OS will be assessed with Kaplan-Meier method from the date of last remission before randomization until the date of death from any cause

Time frame: 2 years

Incidence of graft-versus-host disease

Incidence of acute GVHD, grades I-IV

Time frame: up to 12 months

Treatment-related adverse events as assessed by CTCAE v4.03

Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).

Time frame: up to 12 months

Data from ClinicalTrials.gov

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