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Genetically Risk-Stratified Venetoclax, Ibrutinib, Rituximab (± Navitoclax) in Relapsed/Refractory Mantle Cell Lymphoma

NCT05864742 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-08-12

No results posted yet for this study

Summary

This is an open label, multi-centre, phase II study in which RR MCL patients will be genetically risk-stratified into Standard risk (no 9p21.1-24.3 loss, no SMARCA2 or SMARCA4 mut/del) and High risk (9p21.1-24.3 loss, SMARCA2 and/or SMARCA4 mut/del).

Patients without the high-risk mutations will be treated with ibrutinib, rituximab and venetoclax. Patients with the high-risk mutations will be treated with ibrutinib, rituximab, venetoclax and navitoclax.

Conditions

  • Mantle Cell Lymphoma Refractory

Interventions

DRUG

Ibrutinib

560 mg daily continuously

DRUG

Venetoclax

Oral daily. Dose escalation every 7 days (if no TLS) 20mg, 50mg, 100mg, 200mg and 400mg

DRUG

Navitoclax

Oral daily. Dose-escalation every 14 days (if plt \>75x10\^9/L) 50mg, 100mg, 150mg, and 200mg (target dose)

DRUG

Rituximab

375mg/m2, intravenous. To be given on day 1 of weeks 1, 2, 3, 4 of C1 and day 1 of C2-C8

Sponsors & Collaborators

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-07
Primary Completion
2026-06-01
Completion
2029-06-01

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05864742 on ClinicalTrials.gov