Clinical trial NCT06363994: A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
Official title: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Mantle Cell Lymphoma
Lead sponsor: InnoCare Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 476
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: 28 days
measure: Progression-free Survival (PFS) for Arm A vs. Arm B
timeFrame: Approximately 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical University
city: Changchun
country: China
facility: First Hospital of Jilin University
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Chongqing
country: China
facility: Chongqinq Cancer Hospital
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Dalian
country: China
facility: The second Hospital of Dalian Medical University
city: Fuzhou
country: China
facility: Fujing Cancer Hospital
city: Fuzhou
country: China
facility: Union Hospital Affiliated to Fujian Medical University
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Zhejiang University Medical School affiliated to the first Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Jinan,
country: China
facility: Shandong Provincial Hospital
city: Jinan
country: China
facility: Cancer Hospital of Shandong First Medical University
city: Jinan
country: China
facility: The First Affiliated Hospital of Ningbo University
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science & Technology
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
city: Shanghai
country: China
facility: Cancer Hospital Affiliated to Fudan University
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Wuhan
country: China
facility: Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
city: Wuhan
country: China
facility: Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
city: Wulumuqi
country: China
facility: The Tumor Hospital Affiliated to Xinjiang Medical University
city: Xi'an
country: China
facility: The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)
city: Xi'an
country: China
facility: The Second Affiliated Hospital Of Xi'an Jiaotong University
city: Yibin
country: China
facility: Yibin Second People's Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
Study officials:
References: