Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT05455294
Brief Summary:
The purpose of this research study is to test the safety of a new three drug combination of navitoclax, decitabine, and venetoclax to treat advanced myeloid malignancies.
The names of the drugs involved in this study are:
* Venetoclax
* Decitabine
* Navitoclax
Detailed Description:
This is a phase 1 study to determine the safety, dosing schedule and recommended phase 2 dose of a triplet therapy with navitoclax, venetoclax, and decitabine for patients with the four high-risk myeloid malignancy subgroups of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myeloproliferative neoplasm (MDS/MPN) and myelofibrosis accelerated phase (MF-AP).
The U.S. Food and Drug Administration (FDA) has not approved the combination of venetoclax, navitoclax, and decitabine navitoclax as a treatment for any disease.The FDA has approved the combination of venetoclax and decitabine for acute myeloid leukemia (AML) and decitabine given alone is approved for myelodysplastic syndrome (MDS).
The research study procedures include screening for eligibility, study treatments, and blood tests and bone marrow biopsies to assess response to treatment.
Participants will receive the study treatment regimen as long as it is effective.
It is expected that about 36 people will take part in this research study.
AbbVie, a pharmaceutical company, is supporting this research study by providing funding and the study drugs navitoclax and venetoclax.
Study:
NCT05455294
Study Brief:
Protocol Section:
NCT05455294