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AzTrials

Acute Myeloid LeukemiaPhase 2NCT03381118

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

A Phase 2 study testing Cytarabine, Nivolumab and G-CSF mobilized HLA-haploidentical donor PBSC in people with Acute Myeloid Leukemia, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Cytarabine, Nivolumab and G-CSF mobilized HLA-haploidentical donor PBSC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteRussia
Study dates
30 Jun 2017to 30 Sep 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Boris V Afanasyev, MD, Prof.

    Saint Petersburg, 197089

Other trials in Russia

About this study

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.

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)

Being tested
Cytarabine, Nivolumab, G-CSF mobilized HLA-haploidentical donor PBSC
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CytarabineDrug

    Also called Ara-C

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

  • NivolumabDrug

    Also called Opdivo

    Nivolumab 40 mg IV infusion on D+5

  • CytarabineDrug

    Also called Ara-C

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

  • NivolumabDrug

    Also called Opdivo

    Nivolumab 40 mg IV infusion on D+1

  • G-CSF mobilized HLA-haploidentical donor PBSCBiological

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

Study groups in NCT03381118
Study groupRoleWhat they receive
Ara-C+HaploLymphocyte+NivoExperimentalPatients 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
Receives: Drug: Cytarabine; Drug: Nivolumab; Biological: G-CSF mobilized HLA-haploidentical donor PBSC
Ara-C+ NivoExperimentalPatients 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
Receives: Drug: Cytarabine; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

Secondary outcomes (3)

  1. 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

    Measured: 2 years

  2. Incidence of graft-versus-host disease

    Incidence of acute GVHD, grades I-IV

    Measured: up to 12 months

  3. 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).

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2017
  2. Study start30 Jun 2017
  3. Primary completion30 Sep 2018
  4. Study completion30 Sep 2018

Why it stopped: Unexpected toxicity

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03381118
Sponsor's protocol ID
31/17-n
Status last verified
Apr 2019
First submitted
18 Dec 2017
Last updated
5 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cytarabine, Nivolumab and G-CSF mobilized HLA-haploidentical donor PBSC in people with Acute Myeloid Leukemia, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Unexpected toxicity). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03381118.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.

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