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

InnoCare Pharma

Status and phase: Not yet enrolling; Phase 3

Conditions: Mantle Cell Lymphoma

Treatments: Drug: Rituximab; Drug: Bendamustine Injection; 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

1. 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.
2. Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.
3. Histopathological confirmed MCL.
4. 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).
5. ECOG PS score of 0 to 2.

Exclusion criteria

1. Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
2. Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy.
3. Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant.
4. 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.
5. Known central nervous system lymphoma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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490 participants in 3 patient groups, including a placebo group

Arm A

Active Comparator group

Treatment:

Drug: Rituximab

Drug: Bendamustine Injection

Drug: Orelabrutinib

Arm B

Active Comparator group

Treatment:

Drug: Orelabrutinib Placebo

Drug: Rituximab

Drug: Bendamustine Injection

Drug: Orelabrutinib

Arm C

Placebo Comparator group

Treatment:

Drug: Orelabrutinib Placebo

Drug: Rituximab

Drug: Bendamustine Injection