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

Sponsor
Israeli Medical Association
Study ID
NCT05054465
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Navitoclax — DRUG
    P.O 50mg QD Q28 days for 2 cycles pre-transplant Up to 50mg QD Q28 days maintnance post-transplant based on MTD
  • Venetoclax — DRUG
    P.O 400mg QD Q28 days for 2 cycles pre-transplant Up to 400mg QD Q28 days maintnance post-transplant based on MTD

Study Details

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).

Key Dates

Start date
Oct 1, 2021
Status verified
Jun 2021
Primary completion
Aug 1, 2025
Completion
Aug 1, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pre-transplant consolidation and post-transplant maintnance with navitoclax and venetoclax.
    Patients will be treated with VEN 400 mg QD and NAV 50mg QD according to the RP2D presented by Pullarkat et al. (doi: 10.1158/2159-8290.CD-20-1465) for two 28 day cycles. Following 2 cycles re-staging marrow including MRD assessment and imaging will be followed by alloSCT according to local protocol.Within 90 days from alloSCT patients will be started on VEN and NAV maintenance. For post-alloSCT maintenance a dose escalation scheme based on the BOIN design will be applied with a maximal dose of VEN 400 mg QD and NAV 50mg QD according to the RP2D presented by Pullarkat et al.

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: 2 years ]

Central Contacts

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