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

Acute Myeloid Leukemia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03381118
• Other study ID #: 31/17-n
• Status: Terminated
• Phase: Phase 2
• Start date: June 30, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: April 2019
• Source: St. Petersburg State Pavlov Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Cytarabine
Cytarabine 500-1000 mg/m2 bid IV infusion on D-4, -3, -2
• Nivolumab
Nivolumab 40 mg IV infusion on D+5
• Cytarabine
Cytarabine 500-1000 mg/m2 bid IV infusion on D+1, +2, +3
• 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

Locations

Country	Name	City	State
Russian Federation	Boris V Afanasyev, MD, Prof.	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

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