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

I

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

  • 65 < age <80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator
  • 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.
  • No previous systemic treatment for MCL.
  • ECOG physical strength score is 0-2.
  • Expected survival time >6 months.
  • Voluntary written informed consent prior to screening.

Exclusion criteria

  • Uncontrolled or significant cardiovascular diseases
  • History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment.
  • Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance;
  • Pregnant or breastfeeding women and those who do not agree to take contraceptive measures.
  • 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

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

Trial contacts and locations

0

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Central trial contact

April Huang; Xinghua Zhao

Data sourced from clinicaltrials.gov

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