A Global Phase 3 Study of Orelabrutinib+BR vs.BR in Pts With TN MCL

I

InnoCare Pharma

Status and phase

Not yet enrolling
Phase 3

Conditions

Mantle Cell Lymphoma

Treatments

Drug: Bendamustine Injection
Drug: Rituximab
Drug: Orelabrutinib Placebo
Drug: Orelabrutinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06363994
ICP-CL-00128

Details and patient eligibility

About

Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)

Enrollment

490 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects who are ≥ 60 years old and are ineligible for stem cell transplant or have refused stem cell transplantation due to reason(s) including: Have not received prior therapies (including surgery for therapeutic purposes, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) for MCL.
  • Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.
  • Histopathological confirmed MCL.
  • At least one measurable site of disease (the longest axis of the lymph node lesion is > 1.5 cm, or the longest diameter of the extranodal lesion is > 1.0 cm).
  • ECOG PS score of 0 to 2.

Exclusion criteria

  • Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
  • Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy.
  • Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant.
  • Use of strong inhibitors or strong inducers of cytochrome P450 3A within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment; or plan to use strong inhibitors or strong inducers of CYP3A during the study.
  • Known central nervous system lymphoma.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

490 participants in 3 patient groups, including a placebo group

Arm A
Active Comparator group
Treatment:
Drug: Orelabrutinib
Drug: Rituximab
Drug: Bendamustine Injection
Arm B
Active Comparator group
Treatment:
Drug: Orelabrutinib
Drug: Orelabrutinib Placebo
Drug: Rituximab
Drug: Bendamustine Injection
Arm C
Placebo Comparator group
Treatment:
Drug: Orelabrutinib Placebo
Drug: Rituximab
Drug: Bendamustine Injection

Trial contacts and locations

0

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Central trial contact

Alexia Lu

Data sourced from clinicaltrials.gov

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