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UNKNOWNPHASE3

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

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP Versus Placebo Plus R-CHOP in Treatment-naïve Patients With MCD Subtype DLBCL

NCT05234684•Beijing InnoCare Pharma Tech Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men and women between 18 and 80 years old
•2. Treatment-naive patients
•3. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) and CD20 positive.
•4. Provide FFPE slices of past or fresh tumor biopsy tissue.
•5. At least one measurable lesion.
•6. Lymphoma International Prognostic Score (IPI) ≥ 2.
•7. Ann Arbor stage II-IV, or stage I with bulky lesion (diameter \> 7.5 cm）
•8. ECOG PS score of 0-2
•9. Subjects who in line with the testing standard of the clinical trial laboratory.
•10. Life expectancy ≥ 6 months.
+1 more criteria

Exclusion Criteria

•1. History of other active malignancies within 5 years of study entry, unless cured without evidence of relapse or metastasis
•2. Lymphoma involving the central nervous system or leptomeningeal metastasis.
•3. Transformed lymphoma, that is transformed from other types of lymphoma.
•4. Primary mediastinal large B-cell lymphoma.
•5. History of stroke or intracranial hemorrhage within 6 months before screening.
•6. 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.
•7. 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.
•8. 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).
•9. Administer live and attenuated vaccines (semi-inactivated) within 28 days prior to first receiving the test drug.
•10. Planned stem cell transplant during the experimental treatment are excluded.
+5 more criteria

Locations (44)

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, China

Anhui Provincal Cancer Hospital

Hefei, Anhui, China

Beijing Hospital

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

The Southwest Hospital of AMU

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital Of XIAMEN University

Xiamen, Fujian, China

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

The First People's Hospital of Foshan

Foshan, Guangdong, China

Guangdong General Hospital

Guangzhou, Guangdong, China

Key Dates

Start Date

November 2, 2022

Primary Completion Date

July 30, 2024

Completion Date

December 30, 2025

Last Updated

February 7, 2024

Enrollment

150

ESTIMATED participants

Conditions

Diffuse Large B Cell Lymphoma (DLBCL)

Interventions

Orelabrutinib + R-CHOP

DRUG

Placebo + R-CHOP

DRUG

Contacts

Weili Zhao

CONTACT

+86 021-64370045 zwl_trial@163.com

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COMPLETEDPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

DALY II USA/ MB-CART2019.1 for DLBCL

A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies

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