Phase I trial of azacitidine plus nivolumab following reduced-intensity allogeneic PBSC transplantation for patients with AML and high-risk myelodysplasia

S
Sherif Farag, MD

Primary Investigator

Overview

The purpose of this study is to find the maximum safe dose of nivolumab alone, and of nivolumab combined with azacitidine after reduced-intensity allogeneic peripheral blood stem cell (PBSC) transplantation. Another purpose is to see how the study drugs affect different aspects of transplant such as infection and disease response.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Acute Myeloid Leukemia, Myelodysplasia, Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia
  • Age: Between 18 Years - 100 Years
  • Gender: All

Inclusion Criteria

Patients must have any of the following hematological malignancies at the time of
transplantation:
a. Acute myeloid leukemia (AML) in first (CR1) or subsequent complete remission (CR2, CR3 or beyond), as defined by less than 5% blasts in the bone marrow and peripheral blood.
b. Myelodysplastic disorder (MDS) of high or very high-risk according to the revised International Prognostic Scoring System (IPSS-R).

Updated on 20 Nov 2022. Study ID: 1905948967 (BTCRC-AML18-342)

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center