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A Phase 3 Study to Compare the Efficacy of ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL).

ConditionRelapsed or Refractory Mantle Cell Lymphoma (MCL)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing InnoCare Pharma Tech Co., Ltd.

About this trial

This study aims to compare the efficacy and safety of ICP-248 in combination with orelabrutinib versus pirtobrutinib in patients with relapsed or refractory mantle cell lymphoma (r/r MCL).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Known intolerance to orelabrutinib or pirtobrutinib treatment.

Received autologous hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the investigational product. Received allogeneic hematopoietic stem cell transplantation at any time in the past.

Patients with other malignancies within 2 years prior to enrollment.

Uncontrolled or significant cardiovascular disease.

Disqualifiers

Known intolerance to orelabrutinib or pirtobrutinib treatment.

Received autologous hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the investigational product. Received allogeneic hematopoietic stem cell transplantation at any time in the past.

Patients with other malignancies within 2 years prior to enrollment.

Uncontrolled or significant cardiovascular disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ICP-248

    Drug

    Administered orally

  • Pirtobrutinib

    Drug

    Administered orally

  • Orelabrutinib

    Drug

    Administered orally

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: ICP-248 in combination with OrelabrutinibExperimental treatment 2 interventions
Group B: PirtobrutinibActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) as assessed by Independent Review Committee (IRC).

Time frame
6 years

Secondary outcomes

1

Investigator-assessed PFS according to Lugano 2014.

Time frame
6 years
2

IRC-assessed and investigators-assessed overall response rate (ORR) according to Lugano 2014

Time frame
6 years
3

IRC-assessed and investigators-assessed complete response rate (CRR) according to Lugano 2014

Time frame
6 years
4

IRC-assessed and investigators-assessed duration of response (DOR) according to Lugano 2014

Time frame
6 years

Other outcomes

Sponsors and contacts

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

Beijing InnoCare Pharma Tech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: