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New treatment option for Mantle Cell Lymphoma
Official title A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
ClinicalTrials.gov ID: NCT06363994
What this study is testing
What is Orelabrutinib?
Orelabrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for mantle cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- people ≥ 65 of age, or ≥ 60 and \< 65 years old who are ineligible for stem cell transplant or have refused stem cell transplantation due to...
- 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, expression of Cyclin D1 and/or t (11; 14) chromosomal translocation. Either fresh tissue or FFPE for diagnosis must...
- 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...
- ECOG PS score of 0 to 2.
You likely can't join if
- Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
- people with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or people who have undergone total gastrectomy.
- people 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...
- Known central nervous system lymphoma.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Bengbu, China
- Changchun, China
- Changsha, China
- Changzhou, China
- Chengdu, China
- Chongqing, China
- Dalian, China
- Fuzhou, China
- Guangzhou, China
- Hangzhou, China
- Hefei, China
- Jinan, China
- Luoyang, China
- Nanchang, China
- Nanjing, China
- Shanghai, China
- Shenyang, China
- Shijiazhuang, China
- Taiyuan, China
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Bengbu, China; Changchun, China; Changsha, China; Changzhou, China; Chengdu, China and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.