A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL

Phase 3

Recruiting

• Conditions: Mantle Cell Lymphoma
• Interventions: Drug: Orelabrutinib; Drug: Bendamustine Injection; Drug: Rituximab; Drug: Orelabrutinib Placebo

• Registration Number: NCT06363994
• Lead Sponsor: InnoCare Pharma Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-12
• Study Start: 2024-05-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Primary Completion: 2031-06-25
• Study Completion: 2032-06-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 476

Inclusion Criteria

1. Subjects ≥ 65 of age, or ≥ 60 and < 65 years old who are ineligible for stem cell transplant or have refused stem cell transplantation due to reason(s) including: Have not received prior systemic therapies 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, expression of Cyclin D1 and/or t (11; 14) chromosomal translocation. Either fresh tissue or FFPE for diagnosis must be sent to central lab for final confirmation after randomization.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Orelabrutinib	-
Arm A	Bendamustine Injection	-
Arm A	Rituximab	-
Arm B	Bendamustine Injection	-
Arm B	Rituximab	-
Arm B	Orelabrutinib Placebo	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT)	28 days
Progression-free Survival (PFS) for Arm A vs. Arm B	Approximately 7 years

Trial Locations

Locations (38)

Beijing Cancer Hospital; 🇨🇳 Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, China

The First Affiliated Hospital of Bengbu Medical University; 🇨🇳 Bengbu, China

First Hospital of Jilin University; 🇨🇳 Changchun, China

Hunan Cancer Hospital; 🇨🇳 Changsha, China

The First People's Hospital of Changzhou; 🇨🇳 Changzhou, China

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, China

Chongqinq Cancer Hospital; 🇨🇳 Chongqing, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China

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