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A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma

ConditionMantle Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangzhou Lupeng Pharmaceutical Company LTD.

About this trial

Mantle cell lymphoma (MCL) is an aggressive yet often indolent type of B-cell non-Hodgkin lymphoma (NHL). Rocbrutinib (LP-168) is a novel, highly selective, fourth-generation Bruton's tyrosine kinase (BTK) inhibitor that exhibits both covalent (irreversible) and non-covalent (reversible) binding. This unique dual mechanism of action has shown promising efficacy and a favorable safety profile across various B-cell NHL subtypes in prior Phase 1 and 2 studies. This is a Phase 3, randomized, open-label study comparing Rocbrutinib versus investigator's choice of BTK inhibitor (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) in patients with MCL who have received at least one prior line of therapy and are naïve to BTK inhibitor treatment (except for intolerance).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with MCL, who have received at least one prior systemic regimen(s), and have experienced disease progression on the most recent line of therapy.

Have at least one measurable lesion according to the Lugano Response Criteria 2014.

Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.

Life expectancy ≥ 12 weeks.

Disqualifiers

Hypersensitivity to Rocbrutinib or any study drug in the control group.

Prior treatment with any BTK-targeted therapy (except for intolerance).

Central nervous system (CNS) involvement by lymphoma.

History of other malignancy (except MCL) within the past 2 years, excluding radically cured skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, localized squamous cell carcinoma, etc.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rocbrutinib

    Drug

    Rocbrutinib at 150 mg once daily orally until disease progression or unacceptable toxicity

  • Ibrutinib

    Drug

    Ibrutinib, 560 mg once daily orally and continuously

  • Acalabrutinib

    Drug

    Acalabrutinib, 100 mg twice daily orally and continuously

  • Zanubrutinib

    Drug

    Zanubrutinib, 160 mg twice daily orally and continuously

  • Orelabrutinib

    Drug

    Orelabrutinib, 150 mg once daily orally and continuously

Treatment groups

394 Participants
are divided into 2 treatment groups
Group A: Arm A (Rocbrutinib)Experimental treatment 1 intervention
Group B: Arm B (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib)Active comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) assessed by IRC

Time frame
approximately 30 months

Secondary outcomes

1

PFS assessed by INV

Time frame
approximately 30 months
2

Overall Response Rate (ORR) assessed by IRC and INV, respectively

Time frame
Up to approximately 24 months
3

Duration of Response (DOR) assessed by IRC and INV, respectively

Time frame
approximately 30 months
4

Overall Survival

Time frame
approximately 40 months

Other outcomes

Sponsors and contacts

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

Guangzhou Lupeng Pharmaceutical Company LTD.

Lead sponsor

Source ClinicalTrials.gov
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