Status:
TERMINATED
Haploidentical Lymphocytes With Nivolumab/Ara-C as Consolidation in Elderly AML Patients
Lead Sponsor:
St. Petersburg State Pavlov Medical University
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03381118
Start Date
June 30 2017
End Date
September 30 2018
Last Update
April 5 2019
Active Locations (1)
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1
Boris V Afanasyev, MD, Prof.
Saint Petersburg, Russia, 197089