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:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-24 @ 1:16 PM
NCT ID:
NCT06466395
Brief Summary:
To find the recommended dose of hyper-CVAD in combination with venetoclax that can be given to participants with relapsed or refractory leukemia.
Detailed Description:
Primary Objectives
* To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of venetoclax in combination with hyper-CVAD in patients with relapsed or refractory acute leukemias that are of the lymphoid lineage including bi-phenotypic or undifferentiated leukemias.
* To characterize the safety and tolerability of hyper-CVAD in combination with venetoclax.
Secondary Objectives
* To determine the preliminary assessment of efficacy by overall response (OR), including complete remission (CR), CR with incomplete blood count recovery (CRi) and partial response (PR).
* Evaluate additional measures of clinical benefit including overall survival (OS), event-free survival (EFS), progression-free survival (PFS) minimal residual disease (MRD) rate, and duration of response (DOR).
Exploratory Objectives
. To evaluate the pharmacodynamics (PD) and biological effects of hyper-CVAD in combination with venetoclax through molecular and cellular markers that may be predictive of antitumor activity and/or resistance.
Study:
NCT06466395
Study Brief:
Protocol Section:
NCT06466395