Nivolumab in Eliminating Minimal Residual Disease and Preventing Relapse in Patients With Acute Myeloid Leukemia in Remission After Chemotherapy

Titre officiel

Randomized Phase II Study to Assess the Role of Nivolumab as Single Agent to Eliminate Minimal Residual Disease and Maintain Remission in Acute Myelogenous Leukemia (AML) Patients After Chemotherapy (REMAIN TRIAL)

Sommaire:

Cet essai clinique de phase II à répartition aléatoire étudie le bon fonctionnement du nivolumab pour l'élimination des cellules cancéreuses restantes et la prévention de la récidive du cancer chez des patients atteints de leucémie myéloïde aiguë ayant noté une réduction ou une disparition des signes et des symptômes de cancer après une chimiothérapie. Les anticorps monoclonaux, comme le nivolumab, peuvent inhiber la croissance du cancer de différentes façons en ciblant certaines cellules.

Description de l'essai

Primary Outcome:

  • Progression free survival (PFS)
Secondary Outcome:
  • Overall survival (OS)
  • Non-relapse mortality (NRM)
  • Incidence of adverse effects of nivolumab
PRIMARY OBJECTIVES:
  • To evaluate and compare the progression free survival rate after randomization in the two treatment arms (nivolumab versus [vs.] observation).
SECONDARY OBJECTIVES:
  • To determine and compare the overall survival rates in the two arms.
  • To determine and compare the incidence of non-relapse mortality in the two arms.
  • To evaluate the toxicities of nivolumab as maintenance.
EXPLORATORY OBJECTIVES:
  • To analyze programmed cell death (PD)-ligand (L)1 expression on acute myeloid leukemia (AML) cells from peripheral blood and/or bone marrow samples at diagnosis if available and at the time of study enrollment.
  • To monitor AML minimal residual disease (MRD) by Wilms tumour 1 (WT1) polymerase chain reaction (PCR) at enrollment and at subsequent defined time points in the nivolumab-treated and control groups.
  • To perform an exploratory analysis on the frequencies, absolute numbers and subsets of T cells (including regulatory T cells) in the nivolumab-treated and control groups with an emphasis on activation markers.
  • To perform deep sequencing of T cell receptor (TCR)-alpha and TCR-beta chains on polyclonal T cells at baseline and at subsequent time points in the nivolumab and control groups.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive nivolumab intravenously (IV) over 60 minutes once every 2 weeks. Treatment repeats every 2 weeks for 46 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo standard of care clinical observation for up to 2 years. Upon disease relapse, patients may cross-over to Arm I. After completion of study treatment, patients are followed up periodically for 2 years, every 6 months for 1 year, and then yearly thereafter.

Voir cet essai sur ClinicalTrials.gov

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