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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAustralasian Leukaemia and Lymphoma Group

About this trial

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

Eligibility criteria

Qualifiers

Ages 18 years old or above

A confirmed diagnosis of MCL according to World Health Organization (2016) criteria

At least one site of measurable disease not previously irradiated (defined as at least one bi-dimensionally measurable nodal lesion of greater than or equal to 1.5cm in longest dimension)

Life expectancy (in the opinion of the investigator) of greater than or equal to 18 weeks

Disqualifiers

Inability to comply with protocol mandated hospitalisations

For patients enrolling on the safety cohort, a history of allogeneic transplantation within 12 months of enrolment or ongoing chronic GVHD or immunosuppressive therapy.

Autologous SCT or CAR-T therapy within 6 weeks of enrolment

Active central nervous system involvement with MCL

Trial design

Treatments tested in this trial

  • Glofitamab
  • Pirtobrutinib
  • Obinutuzumab
  • Tocilizumab

Treatment groups

42 Participants
are divided into 1 treatment group