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

2019-10-21 12:45:29 | BioPortfolio

Summary

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.

Study Design

Conditions

Aml

Intervention

Nivolumab, Azacitidine

Location

Indiana University Melvin and Bren Simon Cancer Center
Indianapolis
Indiana
United States
46202

Status

Recruiting

Source

Big Ten Cancer Research Consortium

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-21T12:45:29-0400

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Medical and Biotech [MESH] Definitions

A pyrimidine analogue that inhibits DNA methyltransferase, impairing DNA methylation. It is also an antimetabolite of cytidine, incorporated primarily into RNA. Azacytidine has been used as an antineoplastic agent.

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