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

NCT03381118 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-04-05

No results posted yet for this study

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

Interventions

DRUG

Cytarabine

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

DRUG

Nivolumab

Nivolumab 40 mg IV infusion on D+5

DRUG

Cytarabine

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

DRUG

Nivolumab

Nivolumab 40 mg IV infusion on D+1

BIOLOGICAL

G-CSF mobilized HLA-haploidentical donor PBSC

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

Sponsors & Collaborators

  • St. Petersburg State Pavlov Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03381118 on ClinicalTrials.gov