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

A Randomized Study of Haploidentical Lymphocytes With Nivolumab and Intermediate Dose Cytarabine Versus Nivolumab and Intermediate Dose Cytarabine as Consolidation Treatment in Older Adults With Acute Myeloid Leukemia.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03381118

Enrollment

Registered

2017-12-21

Start date

2017-06-30

Completion date

2018-09-30

Last updated

2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

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)

Interventions

DRUGCytarabine

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

DRUGNivolumab

Nivolumab 40 mg IV infusion on D+5

BIOLOGICALG-CSF mobilized HLA-haploidentical donor PBSC

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Disease-free survival	2 years	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

Secondary

Measure	Time frame	Description
Overall survival	2 years	OS will be assessed with Kaplan-Meier method from the date of last remission before randomization until the date of death from any cause
Incidence of graft-versus-host disease	up to 12 months	Incidence of acute GVHD, grades I-IV
Treatment-related adverse events as assessed by CTCAE v4.03	up to 12 months	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).

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026