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

NCT03381118 | Terminated Phase 2

• 1 other identifier: 31/17-n
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (3)

• Overall survival

  2 years

• Incidence of graft-versus-host disease

  up to 12 months

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

  up to 12 months

Study Arms (2)

Ara-C+HaploLymphocyte+Nivo

EXPERIMENTAL

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

Drug: Cytarabine; Drug: Nivolumab; Biological: G-CSF mobilized HLA-haploidentical donor PBSC

Ara-C+ Nivo

EXPERIMENTAL

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

Drug: Cytarabine; Drug: Nivolumab

Interventions

Cytarabine DRUG

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

Also known as: Ara-C

Ara-C+HaploLymphocyte+Nivo

Nivolumab DRUG

Nivolumab 40 mg IV infusion on D+5

Also known as: Opdivo

Ara-C+HaploLymphocyte+Nivo

G-CSF mobilized HLA-haploidentical donor PBSC BIOLOGICAL

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

Ara-C+HaploLymphocyte+Nivo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead

Study Sites (1)

Boris V Afanasyev, MD, Prof.

Saint Petersburg, 197089, Russia

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine; Nivolumab

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-director for science of R.M. Gorbacheva Memorial Institute of Hematology, Oncology and Transplantation

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 21, 2017
• Study Start: June 30, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: April 5, 2019

Record last verified: 2019-04

Locations

RU (1)