Phase II Study to Evaluate Safety and Efficacy of CB-103 With Venetoclax in Adolescent and Young Adult Patients With Relapsed/Refractory T-ALL or T-LBL

Leukemia Clinical Trial

Official title: A Phase II Study to Evaluate Safety and Efficacy of CB-103 in Combination With Venetoclax in Adolescent and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)

Status Recruiting

Clinical Trial Summary

To learn if the combination of 2 study drugs, CB-103 and venetoclax, can help to control T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic leukemia (T-LBL) in adolescent and young adult patients

Clinical Trial Description

Primary Objectives:

• To characterize the safety and tolerability of CB-103 in combination with Venetoclax in adolescent (12 to 18 years) and adult (19 to 60 years) patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).

• To assess the efficacy of CB-103 in combination with venetoclax by the overall response rate (ORR), defined as complete remission (CR), plus CR with incomplete blood count recovery (CRi) [1] plus partial remission (PR) [2], in adolescent, and young adult patients with relapsed/refractory T-ALL/T-LBL.

Secondary Objectives:

• To assess whether the ORR to CB-103 in combination with Venetoclax is dependent on pre-treatment expression of Notch and/or BCL2 pathway.

• To determine the preliminary assessment of CB-103 in combination with Venetoclax by other efficacy parameters such as minimal residual disease (MRD), duration of response (DoR), overall survival (OS) and event-free survival (EFS) in adolescent and young adult patients with relapsed/refractory T-ALL/T-LBL.

Exploratory Objectives:

• To explore potential correlations of ORR to treatment and additional pharmacodynamic (PD) markers, i.e., other oncogenic pathway activations that may co-occur at the start of treatment.

• To evaluate how many patients are able to transition to Hematopoietic Stem Cell

Transplant (HSCT):

• Either in the patients achieving CR after the induction and reinduction cycles;

• Or in the patients with PR or stable disease (SD) after the induction and reinduction. ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoblastic
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT05464836
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: Miriam Garcia, DO
• Phone: (713) 745-4312
• Email: mbgarcia@mdanderson.org
• Status: Recruiting
• Phase: Phase 2
• Start date: April 6, 2023
• Completion date: July 1, 2026