A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With MCD Subtype Diffuse Large B-cell Lymphoma

NCT05234684 | Recruiting Phase 3

• 1 other identifier: ICP-CL-00115
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 44

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP regimen versus placebo with R-CHOP in the treatment of treatment-naïve patients with MCD subtype DLBCL.

Conditions

Diffuse Large B Cell Lymphoma (DLBCL)

Outcome Measures

Primary Outcomes (2)

• Progression free survival (PFS)

  Progression free survival (PFS) accessed by independent review committee (IRC)

  Up to 3 years and 9 months

• Complete response rate (CRR) by independent review committee (IRC)

  Complete response rate (CRR) at the completion of combination therapy accessed by independent review committee (IRC)

  Up to 3 years and 9 months

Secondary Outcomes (7)

• Complete response rate (CRR) by investigator

  Up to 3 years and 9 months

• Overall response rate (ORR) by independent review committee (IRC) and investigator

  Up to 3 years and 9 months

• Overall response rate (ORR) at the completion of combination therapy by independent review committee (IRC) and investigator

  Up to 3 years and 9 months

• Duration of Response (DOR)

  Up to 3 years and 9 months

• Disease free survival (DFS) rate and event free survival (EFS) rate

  Up to 2 years

Study Arms (2)

Orelabrutinib+ R-CHOP

EXPERIMENTAL

Participants will receive 150 mg of oral orelabrutinib once daily with R-CHOP on day 1 of each cycle (21 days).

Drug: Orelabrutinib + R-CHOP

Placebo+ R-CHOP

PLACEBO COMPARATOR

Participants will receive 150 mg placebo once daily with R-CHOP on day 1 of each cycle (21 days).

Drug: Placebo + R-CHOP

Interventions

Orelabrutinib + R-CHOP DRUG

The orelabrutinib is a white, round, uncoated tablet. The R-CHOP include rituximab, cyclophosphamide, doxorubicin, vincristine, and prednison.

Also known as: ICP-022+ R-CHOP

Orelabrutinib+ R-CHOP

Placebo + R-CHOP DRUG

The placebo is a white, round, uncoated tablet. The R-CHOP include rituximab, cyclophosphamide, doxorubicin, vincristine, and prednison.

Placebo+ R-CHOP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between 18 and 80 years old
• Treatment-naive patients
• Histologically confirmed diffuse large B-cell lymphoma (DLBCL) and CD20 positive.
• Provide FFPE slices of past or fresh tumor biopsy tissue.
• At least one measurable lesion.
• Lymphoma International Prognostic Score (IPI) ≥ 2.
• Ann Arbor stage II-IV, or stage I with bulky lesion (diameter \> 7.5 cm）
• ECOG PS score of 0-2
• Subjects who in line with the testing standard of the clinical trial laboratory.
• Life expectancy ≥ 6 months.
• Able to provide signed written informed consent.

You may not qualify if:

• History of other active malignancies within 5 years of study entry, unless cured without evidence of relapse or metastasis
• Lymphoma involving the central nervous system or leptomeningeal metastasis.
• Transformed lymphoma, that is transformed from other types of lymphoma.
• Primary mediastinal large B-cell lymphoma.
• History of stroke or intracranial hemorrhage within 6 months before screening.
• Co-morbidity of uncontrolled or significant cardiovascular disease, significant impaired lung function, significant gastrointestinal abnormalities, uncontrolled infections (including HBV, HCV, HIV/AIDS and tuberculosis), or active autoimmune disease.
• Active bleeding within 2 months before screening, or a clear bleeding tendency determined by the investigator; a history of deep vein thrombosis or pulmonary embolism.
• Previous history of surgeries (major 4 weeks and minor 2 weeks prior screening) , organ transplant or hematopoietic stem cell transplantation, or progressive multifocal leukoencephalopathy (PML).
• Administer live and attenuated vaccines (semi-inactivated) within 28 days prior to first receiving the test drug.
• Planned stem cell transplant during the experimental treatment are excluded.
• Chemotherapy, immunotherapy, targeted therapy, radiotherapy, or traditional Chinese medicine with anti-tumor effects for the purpose of anti-tumor therapy within 4 weeks before starting to take the experimental drug. Excluding short-term emergency use of corticosteroids before treatment.
• Current diagnosis of any mental or cognitive impairment, drug abuse, or alcohol abuse.
• Pregnant, lactating women, or women at childbearing ages who will not use contraception during the study up to 12 months after the last dose of rituximab or 180 days after the last dose of study drug
• The last use of strong CYP3A inhibitor or strong CYP3A inducer is less than 5 halflivesfrom the first trial drug, or the drug or food with moderate and strong CYP3A inhibitory effect or strong CYP3A induction effect is planned to be taken at the same time during this study.
• Any serious medical condition that, in the investigator's opinion, would put the subject at unacceptable risk and/or would prevent the subject from signing the informed consent form. In the opinion of the investigator, the subject's participation in the study would be at unacceptable risk.

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (44)

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, 233000, China

RECRUITING

Anhui Provincal Cancer Hospital

Hefei, Anhui, 230031, China

RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

The Southwest Hospital of AMU

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

The First Affiliated Hospital Of XIAMEN University

Xiamen, Fujian, 361003, China

RECRUITING

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, 730050, China

RECRUITING

The First People's Hospital of Foshan

Foshan, Guangdong, 528000, China

RECRUITING

Guangdong General Hospital

Guangzhou, Guangdong, 510180, China

RECRUITING

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510700, China

RECRUITING

PEKING University SHENZHEN Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

Sun Yat-sen University Cancer Center Internal medicine department

Guandong, Guangzhou, 510060, China

RECRUITING

Affiliated Hospital of Hebei University

Baoding, Hebei, 050031, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

The First Affiliated Hospital of Henan University of science and Technology

Luoyang, Henan, 450052, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430023, China

RECRUITING

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

Chenzhou first people's Hospital

Chenzhou, Hunan, 423099, China

RECRUITING

The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Wuxi People's Hospital

Wuxi, Jiangsu, 214043, China

RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330001, China

RECRUITING

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116023, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110002, China

RECRUITING

Qilu Hospital Of Shandong University

Jinan, Shandong, 250000, China

RECRUITING

Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250021, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266400, China

RECRUITING

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

ACTIVE NOT RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai 6th People's Hospital

Shanghai, Shanghai Municipality, 201306, China

ACTIVE NOT RECRUITING

The first Affiliated Hospital Of Xi'an Jiaotong University

Xi’an, Shanxi, 710004, China

ACTIVE NOT RECRUITING

The Second Affiliated Hospital Of Xi'an Jiaotong University

Xi’an, Shanxi, 710004, China

RECRUITING

West China Hospital Sichuan University

Chengdu, Sichuan, 610000, China

ACTIVE NOT RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830000, China

RECRUITING

The first affiliated Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Sir Run Run Shaw Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang, 310016, China

RECRUITING

Shaoxing People's Hospital

Shaoxing, Zhejiang, 312000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

orelabrutinib

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Weili Zhao

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weili Zhao

CONTACT

+86 021-64370045; zwl_trial@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2022
• First Posted: February 10, 2022
• Study Start: November 2, 2022
• Primary Completion: July 30, 2024
• Study Completion: December 30, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

CN (44)