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A Phase 2 Trial of GlOfitamab anD pIrtobrutinib in Mantle Cell Lymphoma Patients With Prior BTK Inhibitor Exposure.

NCT05833763 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-01-08

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and response of combining Pirtobrutinib and Glofitimab in patients with relapsed MCL. The main question it aims to answer are:

* Will additive and synergistic effects be observed when using a combination of glofitamab and pirtobrutinib?
* Will this combination be safe and lead to high complete- and remission rates with no residual disease?

Pirtobrutinib will be given to all participants as an oral tablet for the duration of the entire study. Participants will receive other treatment in 3 phases:

1. Treatment Ramp-Up

1. Treatment with Obinutuzumab by Intravenous (IV)
2. An initial dose level of Glofitamab will evaluate step-up dosing. If excessive adverse events are observed, a lower initial dose will be used.
2. Fixed course combination phase: Treatment with Glofitamab by IV
3. Maintenance phase: Glofitamab is discontinued. 200mg oral daily

Conditions

Interventions

DRUG

Glofitamab

Glofitamab is provided as liquid concentrate for IV infusion. Each vial contains 10mg of glofitamab.

DRUG

Pirtobrutinib

Pirtobrutinib is supplied as immediate release film-coated tablets containing 50 mg, or 100 mg of active compound. Tablets are supplied in labelled, HDPE bottles and sealed with child-resistant closures.

DRUG

Obinutuzumab

Obinutuzumab is provided as a single dose 1000 mg liquid concentrate for infusion containing of 25 mg/mL obinutuzumab.

DRUG

Tocilizumab

Tocilizumab is provided as a liquid concentrate for IV infusion. Each vial contains 200mg/10mL concentrate solution

Sponsors & Collaborators

  • Australasian Leukaemia and Lymphoma Group

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-12
Primary Completion
2032-04-30
Completion
2037-04-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

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 NCT05833763 on ClinicalTrials.gov