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Clinical Trial to Assess The Efficacy and Safety of the Combination of Tisagenlecleucel And Ibrutinib in Mantle Cell Lymphoma

NCT04234061 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-11-07

No results posted yet for this study

Summary

This is an open label, multi-center, single-arm, phase II study investigating the efficacy and safety of the combination of ibrutinib and Tisagenlecleucel in twenty patients with relapsed or refractory Mantle Cell Lymphoma (MCL) or who had sub-optimal response to standard therapy in the presence of TP53 mutation.

Conditions

  • Mantle Cell Lymphoma Recurrent

Interventions

COMBINATION_PRODUCT

ibrutinib and Tisagenlecleucel

Single-arm study investigating combination of ibrutinib and Tisagenlecleucel treatment

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • Michael Dickinson · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-07
Primary Completion
2027-09-01
Completion
2030-09-01
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

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 NCT04234061 on ClinicalTrials.gov