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Trial Title:
A Global Phase 3 Study of Orelabrutinib+BR vs.BR in Pts With TN MCL
NCT ID:
NCT06363994
Condition:
Mantle Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Rituximab
Bendamustine Hydrochloride
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Orelabrutinib
Description:
Eligible patients will receive Orelabrutinib orally as per the protocol，until disease
progression or other reasons for treatment discontinuation，whichever comes first.
Arm group label:
Arm A
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
Bendamustine Injection
Description:
Eligible patients will receive Bendamustine by injection as per the protocol
Arm group label:
Arm A
Arm group label:
Arm B
Arm group label:
Arm C
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Eligible patients will receive Rituximab by injection as per the protocol
Arm group label:
Arm A
Arm group label:
Arm B
Arm group label:
Arm C
Intervention type:
Drug
Intervention name:
Orelabrutinib Placebo
Description:
Eligible patients will receive Orelabrutinib Placebo orally as per the protocol
Arm group label:
Arm B
Arm group label:
Arm C
Summary:
Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus
bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
May 25, 2024
Completion date:
December 25, 2035
Lead sponsor:
Agency:
InnoCare Pharma Inc.
Agency class:
Industry
Source:
InnoCare Pharma Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06363994
