A Global Phase 3 Study of Orelabrutinib+BR vs.BR in Pts With TN MCL

Mantle Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06363994
• Other study ID #: ICP-CL-00128
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 25, 2024
• Est. completion date: December 25, 2035

Study information

• Verified date: April 2024
• Source: InnoCare Pharma Inc.
• Contact: Alexia Lu
• Phone: 010-66609745
• Email: CO_HGRAC[@]innocarepharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 490
• Est. completion date: December 25, 2035
• Est. primary completion date: December 25, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

Drug:
• Orelabrutinib
Eligible patients will receive Orelabrutinib orally as per the protocol,until disease progression or other reasons for treatment discontinuation,whichever comes first.
• Bendamustine Injection
Eligible patients will receive Bendamustine by injection as per the protocol
• Rituximab
Eligible patients will receive Rituximab by injection as per the protocol
• Orelabrutinib Placebo
Eligible patients will receive Orelabrutinib Placebo orally as per the protocol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
InnoCare Pharma Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT)		28 days
Primary	Progression-free Survival (PFS) for Arm A vs. Arm C		Approximately 10 years