Azacitidine Plus Nivolumab Following Reduced-intensity Allogeneic PBSC Transplantation for Patients With AML and High-risk Myelodysplasia

Sponsor
Sherif Farag
Study ID
NCT04128020
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab
  • Azacitidine — DRUG
    Azacitidine

Study Details

This is a phase I clinical trial that will define the maximum tolerated dose (MTD) and investigate the feasibility and safety of the combination of nivolumab and azacitidine after reduced-intensity allogeneic PBSC transplantation. Dose escalation will follow a traditional 3+3 design. The investigators will first escalate the dose of single agent nivolumab to determine its MTD (if any, at the doses tested), with an expanded cohort at the MTD or highest dose tested. The investigators will then combine escalating azacitidine in combination of with nivolumab at its determined MTD or highest dose tested in earlier cohorts, and expand the highest dose cohort tested with the combination. Patients will be treated according to the dose level cohorts described in the protocol.

Key Dates

First listed
Oct 16, 2019
Start date
Oct 10, 2019
Status verified
Oct 2020
Primary completion
Sep 28, 2020
Completion
Sep 28, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Nivolumab: 0.3, 0.5, or 1.0 mg/kg IV, days 1 \& 15
  • Experimental: Nivolumab + Azacitidine
    Azacitidine 8,16, 24 mg/m\^2, days 1-5 Nivolumab @MTD (1.0 mg/kg or lower), days 8 \& 15

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of nivolumab [ Time Frame: 1 cycle (42 Days) ]

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