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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    356
  • sponsor
    Beijing InnoCare Pharma Tech Co., Ltd.
Updated on 28 October 2022

Summary

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

Details
Condition Treatment-naїve Mantle Cell Lymphoma
Treatment R-CHOP, Orelabrutinib and R-CHOP
Clinical Study IdentifierNCT05051891
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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
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