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

Investigating Safe Doses for Post-Transplant Treatment

Recruiting
18 years - 100 years
All
1 Location

Brief description of study.

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 of study

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

  • Conditions: Myelodysplasia,Chronic Myelomonocytic Leukemia,Acute Myeloid Leukemia,Myelodysplastic Syndrome
  • Age: 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 19 Feb 2024. Study ID: 1905948967 (BTCRC-AML18-342)

This study investigates the safe dosage levels of an investigational medication alone and in combination with another investigational medication after a type of stem cell transplant. It focuses on patients with blood cancers like acute myeloid leukemia and myelodysplastic disorders. The study aims to understand the effects of these medications on transplant outcomes, including infection and disease response.

Participants will receive either the investigational medication alone or combined with another investigational medication. The study will monitor how the body responds to these treatments and observe any side effects. It will also examine how these treatments impact the success of the stem cell transplant.

  • Who can participate: Adults with acute myeloid leukemia in remission or high-risk myelodysplastic disorders can participate. They must be undergoing a reduced-intensity allogeneic peripheral blood stem cell transplant.
  • Study details: Participants will receive an investigational medication alone or with another investigational medication after their stem cell transplant. A placebo is not used in this study.

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