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

Last updated: October 10, 2022
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphoma

Treatment

N/A

Clinical Study ID

NCT05051891
ICP-CL-00113
  • Ages 60-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 65 < age <80, or 60 ≤ age ≤65 and is ineligible for autologous stem celltransplantation 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 basedon 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

Exclusion Criteria:

  1. Uncontrolled or significant cardiovascular diseases
  2. History of stroke or intracranial hemorrhage within 6 months before firstadministration of study treatment.
  3. Any mental or cognitive impairments which may limit the subject 's understanding andexecution of informed consent as well as study compliance;
  4. Pregnant or breastfeeding women and those who do not agree to take contraceptivemeasures.
  5. Conditions in which a potentially life-threatening illness or severe organ dysfunctionis not considered appropriate by the investigator. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 356
Study Start date:
December 22, 2021
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Anhui Province Cancer Hospital

    Hefei, Anhui 230009
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100143
    China

    Active - Recruiting

  • Tumor in Hunan Province

    Hunan, Changsha 410013
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Site Not Available

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong 510180
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei 50011
    China

    Site Not Available

  • Henan Tumor Hospital

    Zhengzhou, Henan 450008
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Wuhan Union Hospital

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 3300008
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shenyang, Liaojing 110001
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Guangxi, Nanning 530021
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan, Shandong 250021
    China

    Site Not Available

  • West China Hospital,Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Hospital of Hematology, Chinese Academy of Medical Sciences

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Tianjin Cancer Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

  • he First Affiliated Hospital of Zhengjiang University

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.