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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT07052994
Brief Summary:
The goal of Phase 1a of this clinical research study is to find the highest tolerable dose of revumenib that can be given in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin to patients who have acute leukemia.
The goal of Phase 1b of this clinical research study is to learn if the dose of revumenib in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin found in Phase 1a can help to control the disease.
Detailed Description:
Primary Objective:
To determine the safety, tolerability and recommended phase II dose (RP2D) of Revumenib incombination with cytarabine and daunorubicin and Gemtuzumab ozogamicin (GO) in relapsed refractory and frontline pediatric patients with acute leukemias, with primary endpoint defined as DLT (per Section 7.5)
Secondary Objective:
To determine the preliminary assessment of efficacy by overall response (OR), including complete remission (CR), CR with incomplete blood count recovery and partial remission, overall survival (OS), event-free survival (EFS) and duration of response (DOR) of pediatric patients treated with this combination.
Exploratory Objective:
To evaluate molecular and cellular markers that may be predictive of antitumor activity and/or resistance.
Study:
NCT07052994
Study Brief:
Protocol Section:
NCT07052994