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

• Status: Terminated
• Trial end date: 2018-09-30
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Petersburg State Pavlov Medical University
• Treatments: Cytarabine; Nivolumab

Criteria

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