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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07355335
Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of mezigdomide in combination with ziftomenib in adolescent and adult participants with either KMT2A-rearranged (KMT2A-r) or NPM1-mutant relapsed or refractory acute myeloid leukemia (AML).
Detailed Description:
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved ziftomenib and mezigdomide as a treatment for any disease.
Duration of treatment will depend on individual response, evidence of disease progression, and tolerance. The total treatment period will be 12 cycles. If you have completed treatment, you will be followed of up to 12 months. If you do not, complete treatment, you will be followed for 30 days after discontinuation of treatment.
It is expected that about 24 people will take part in this research study.
Study:
NCT07355335
Study Brief:
Protocol Section:
NCT07355335