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

Sponsor
Beijing InnoCare Pharma Tech Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05051891
Collaborator
(none)
356
Enrollment
22
Locations
2
Arms
67
Anticipated Duration (Months)
16.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
356 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Jan 30, 2022
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2027

Arms and Interventions

ArmIntervention/Treatment
Experimental: the experimental group

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

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

Experimental: The control group

R-CHOP

Drug: R-CHOP
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)

Outcome Measures

Primary Outcome Measures

  1. PFS [Up to 6 years]

    To evaluate the Progression-free Survival (PFS) by the Independent Review Committee (IRC) according to the 2014 International Working Group Criteria for Non-Hodgkin Lymphoma (iwNHL).

Secondary Outcome Measures

  1. ORR [Up to 6 years]

    Objective Response Rate

  2. CRR [Up to 6 years]

    Complete Response Rate

  3. OS [Up to 6 years]

    Overall Survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Anhui Province Cancer HospitalHefeiAnhuiChina230009
2Beijing Cancer HospitalBeijingBeijingChina100143
3Tumor in Hunan ProvinceHunanChangshaChina410013
4The First Affiliated Hospital of Xiamen UniversityXiamenFujianChina361003
5Sun Yat-sen University Cancer CenterGuangzhouGuangdongChina510060
6Guangzhou First People's HospitalGuangzhouGuangdongChina510180
7The Fourth Hospital of Hebei Medical UniversityShijiazhuangHebeiChina50011
8Henan Tumor HospitalZhengzhouHenanChina450008
9The First Affiliated Hospital of Zhengzhou UniversityZhengzhouHenanChina450052
10Wuhan Union HospitalWuhanHubeiChina430022
11Jiangsu Province HospitalNanjingJiangsuChina210029
12The First Affiliated Hospital of Soochow UniversitySuzhouJiangsuChina215006
13The First Affiliated Hospital of Nanchang UniversityNanchangJiangxiChina3300008
14The First Hospital of Jilin UniversityChangchunJilinChina130021
15The First Hospital of China Medical UniversityShenyangLiaojingChina110001
16The First Affiliated Hospital of Guangxi Medical UniversityGuangxiNanningChina530021
17Shandong Provincial HospitalJinanShandongChina250021
18West China Hospital,Sichuan UniversityChengduSichuanChina610041
19Hospital of Hematology, Chinese Academy of Medical SciencesTianjinTianjinChina300052
20Tianjin Cancer HospitalTianjinTianjinChina300060
21he First Affiliated Hospital of Zhengjiang UniversityHangzhouZhejiangChina310003
22Zhejiang Cancer HospitalHangzhouZhejiangChina310022

Sponsors and Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing InnoCare Pharma Tech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05051891
Other Study ID Numbers:
  • ICP-CL-00113
First Posted:
Sep 21, 2021
Last Update Posted:
Dec 9, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2021