ONC 201 Maintenance Therapy in Acute Myeloid Leukemia and Myelodysplastic Syndrome After Stem Cell Transplant

Summary

Participation Requirements

Description

This is a single-center pilot study of 20 patients with AML/MDS. Eligible patients will be enrolled following an informed consent between 6-20 weeks after allogeneic hematopoietic stem cell transplant. Patients will receive weekly oral ONC 201 for a total of 52 weeks. The objectives of the study are...

This is a single-center pilot study of 20 patients with AML/MDS. Eligible patients will be enrolled following an informed consent between 6-20 weeks after allogeneic hematopoietic stem cell transplant. Patients will receive weekly oral ONC 201 for a total of 52 weeks. The objectives of the study are: 1. To determine the safety and preliminary efficacy of ONC 201 maintenance therapy among patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), who undergo allogeneic hematopoietic stem cell transplant. 2. To investigate the impact of ONC 201 on reconstitution of NK and other immune cells. Patients will be monitored for toxicities (using Common Terminology Criteria for Adverse Events, CTCAE version 5.0), quality of life (Functional Assessment of Cancer Therapy-Bone Marrow Transplant, FACT-BMT), and immunologic changes. We will specifically investigate the impact of ONC 201 on reconstitution of NK and other immune cells. We will also examine changes in functional status (Karnofsky Performance Scale, KPS, instrumental activities of daily living and short physical performance battery), rates of disease relapse and mortality.

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