A Phase 1b-2 Trial to Assess Venetoclax and Navitoclax Consolidation and Post-transplant Maintenance in High-risk Patients With T-ALL

• Status: Not yet recruiting
• Trial end date: 2026-08-01

Summary

This is a national, multicenter, phase II clinical trial to evaluate the potential benefit of pre-transplant consolidation and post-transplant maintenance with navitoclax and venetoclax in patients with T-ALL, LBL and MPAL T/M in first complete remission designated for allogeneic transplantation.

Pre-transplantation consolidation with venetoclax and navitoclax:

Patients in CR designated for transplantation will be treated with venetoclax 400 mg QD and navitoclax 50mg QD according to the RP2D presented by Pullarkat et al. (Cancer Discov . 2021 Feb 16;candisc.1465.2020. doi: 10.1158/2159-8290.CD-20-1465.) for two 28 day cycles. Following 2 cycles re-staging marrow including MRD assessment and imaging as need will be followed by alloSCT according to local protocol.

Post-transplantation maintenance with venetoclax and navitoclax:

Within 90 days from alloSCT patients will be started on venetoclax and navitoclax maintenance.

Due to lack of data regarding the toxicity of navitoclax and venetoclax in the ALL post alloSCT maintenance setting a dose escalation scheme based on the BOIN design will be applied as outlined (TBD) with a maximal dose of venetoclax 400 mg QD and navitoclax 50mg QD according to the RP2D presented by Pullarkat et al. (Cancer Discov . 2021 Feb 16;candisc.1465.2020. doi: 10.1158/2159-8290.CD-20-1465).

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: Israeli Medical Association
• Collaborators: Hadassah Medical Center; Rabin Medical Center; Rambam Health Care Campus; Shaare Zedek Medical Center; Sheba Medical Center; Soroka University Medical Center; Tel Aviv Medical Center
• Treatments: Navitoclax; Venetoclax