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

ConditionsMantle Cell LymphomaMantle Cell Lymphoma Refractory
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Glofitamab

    Drug

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

  • Pirtobrutinib

    Drug

    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.

  • Obinutuzumab

    Drug

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

  • Tocilizumab

    Drug

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

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Study TreatmentExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

To evaluate the efficacy of combination Pirtobrutinib and Glofitmab in patients with relapsed/refractory MCL and prior BTK inhibitor exposure.

Determined by the complete response (CR) rate according to Lugano criteria

Time frame
Following six cycles (or approximately 18 weeks following first treatment). Cycle 1 is 14 days in duration and cycles 2 to 6 are 21 days in duration.

Secondary outcomes

1

Complete response rate using the Lugano Criteria for response assessment at end of 12 cycles of Glofitamab

Using the Lugano Criteria for response assessment

Time frame
When all patients have completed 12 cycles of Glofitamab. Cycle 1 is 14 days in duration and cycles 2 to 12 are 21 days in duration.
2

Assessment of adverse events (eg. fatigue, diarrhoea, confusion, nausea, constipation, anaemia, dyspnoea)

Incidence, nature and severity of adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).

Time frame
Analysis of the adverse events will be completed in line with the primary and secondary endpoints; When all patients have completed 6 cycles of protocol treatment, when all patients have completed 12 cycles of treatment.
3

Overall response rates (complete or partial response) to combination therapy.

Using the Lugano criteria

Time frame
At the end of combination therapy (cycle 12).Cycle 1 is 14 days in duration and cycles 2 to 12 are 21 days in duration.
4

Overall response rates

Using the Lugano criteria

Time frame
At the end of combination therapy (cycle 12). Cycle 1 is 14 days in duration and cycles 2 to 12 are 21 days in duration.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Australasian Leukaemia and Lymphoma Group

Lead sponsor

Source ClinicalTrials.gov
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