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

Primary Purpose

Acute Myeloid Leukemia

Status

Terminated

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

Cytarabine

Nivolumab

Cytarabine

Nivolumab

G-CSF mobilized HLA-haploidentical donor PBSC

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Boris V Afanasyev, MD, Prof.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Ara-C+HaploLymphocyte+Nivo

Ara-C+ Nivo

Arm Description

Patients treated with nivolumab, intermediate dose cytarabine and haploidentical lymphocyte infusion: [Cytarabine 500-1000 mg/m2 bid D-4, -3, -2 + G-CSF mobilized HLA-haploidentical donor peripheral blood stem cells infusion D0 + Nivolumab 40 mg D+5] х 2-3 cycles

Patients treated with nivolumab and intermediate dose cytarabine: [Cytarabine 500-1000 mg/m2 bid D+1, +2, +3 + Nivolumab 40 mg D+1] х 2-3 cycles

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Incidence of graft-versus-host disease

Incidence of acute GVHD, grades I-IV

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).

Full Information

NCT ID

NCT03381118

First Posted

December 18, 2017

Last Updated

April 3, 2019

Sponsor

St. Petersburg State Pavlov Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03381118

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Terminated

Why Stopped

Unexpected toxicity

Study Start Date

June 30, 2017 (Actual)

Primary Completion Date

September 30, 2018 (Actual)

Study Completion Date

September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

St. Petersburg State Pavlov Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ara-C+HaploLymphocyte+Nivo

Arm Type

Experimental

Arm Description

Arm Title

Ara-C+ Nivo

Arm Type

Experimental

Arm Description

Patients treated with nivolumab and intermediate dose cytarabine: [Cytarabine 500-1000 mg/m2 bid D+1, +2, +3 + Nivolumab 40 mg D+1] х 2-3 cycles

Intervention Type

Drug

Intervention Name(s)

Cytarabine

Other Intervention Name(s)

Ara-C

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo

Intervention Description

Nivolumab 40 mg IV infusion on D+5

Intervention Type

Drug

Intervention Name(s)

Cytarabine

Other Intervention Name(s)

Ara-C

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo

Intervention Description

Nivolumab 40 mg IV infusion on D+1

Intervention Type

Biological

Intervention Name(s)

G-CSF mobilized HLA-haploidentical donor PBSC

Intervention Description

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

Primary Outcome Measure Information:

Title

Disease-free survival

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

OS will be assessed with Kaplan-Meier method from the date of last remission before randomization until the date of death from any cause

Time Frame

2 years

Title

Incidence of graft-versus-host disease

Description

Incidence of acute GVHD, grades I-IV

Time Frame

up to 12 months

Title

Treatment-related adverse events as assessed by CTCAE v4.03

Description

Time Frame

up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Boris V Afanasyev, MD, Prof.

City

Saint Petersburg

ZIP/Postal Code

197089

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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