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

RecruitingPhase 3Ages 60 Years - anyAllInnoCare Pharma Inc.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Subjects โ‰ฅ 65 of age, or โ‰ฅ 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.
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What it tests

  • Orelabrutinib
  • Bendamustine Injection
  • Rituximab
  • Orelabrutinib Placebo
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Where

39 sites
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

โ€ฆand 31 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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