A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma

InnoCare Pharma

Status and phase: Enrolling; Phase 3

Conditions: Treatment-naїve Mantle Cell Lymphoma

Treatments: Drug: R-CHOP; Drug: Orelabrutinib and R-CHOP

Study type: Interventional

Funder types: Industry

Identifiers

NCT05051891

ICP-CL-00113

Details and patient eligibility

About

To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma.

Enrollment: 356 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 65 < age <80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator
2. Histopathological confirmed MCL and either expression of cyclin D1 or t (11;14) chromosomal translocation (in association with CD20). The verification will be based on central review of the local pathology report.
3. No previous systemic treatment for MCL.
4. ECOG physical strength score is 0-2.
5. Expected survival time >6 months.
6. Voluntary written informed consent prior to screening.

Exclusion criteria

1. Uncontrolled or significant cardiovascular diseases
2. History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment.
3. Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance;
4. Pregnant or breastfeeding women and those who do not agree to take contraceptive measures.
5. Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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356 participants in 2 patient groups

the experimental group

Experimental group

Description:

Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)

Treatment:

Drug: Orelabrutinib and R-CHOP

The control group

Experimental group

Description:

R-CHOP

Treatment:

Drug: R-CHOP