NCT05234684RecruitingPhase 3
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
Beijing InnoCare Pharma Tech Co., Ltd.44 sites in 1 country150 target enrollmentStarted: November 2, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 44
- Primary Endpoint
- Progression free survival (PFS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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) ≥
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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).
Intervention: Orelabrutinib + R-CHOP (Drug)
Placebo+ R-CHOP
Placebo Comparator
Participants will receive 150 mg placebo once daily with R-CHOP on day 1 of each cycle (21 days).
Intervention: Placebo + R-CHOP (Drug)
Outcomes
Primary Outcomes
Progression free survival (PFS)
Time Frame: Up to 3 years and 9 months
Progression free survival (PFS) accessed by independent review committee (IRC)
Complete response rate (CRR) by independent review committee (IRC)
Time Frame: Up to 3 years and 9 months
Complete response rate (CRR) at the completion of combination therapy accessed by independent review committee (IRC)
Secondary Outcomes
- 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)
- Overall survival (OS) rate(Up to 2 years)
- Occurrence of adverse events and serious adverse events according to CTCAE V5.0.(Up to 3 years and 9 months)
Investigators
Study Sites (44)
Loading locations...
Similar Trials
Recruiting
Phase 2
Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCLDiffuse Large B-Cell LymphomaNCT05498259The First Affiliated Hospital of Soochow University46
Recruiting
Phase 3
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 LymphomaTreatment-naїve Mantle Cell LymphomaNCT05051891Beijing InnoCare Pharma Tech Co., Ltd.356
Recruiting
Not Applicable
Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local TherapyMarginal Zone LymphomaNCT06478472The First Affiliated Hospital of Xiamen University36
Recruiting
Phase 2
Orelabrutinib Combined With Rituximab and Chemotherapy for Relapsed/Refractory B-Cell Lymphoma Patients With Central Nervous System InvolvementCNS LymphomaNCT05926427Ruijin Hospital25
Recruiting
Phase 3
Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone LymphomaRelapsed/Refractory Marginal Zone LymphomaNCT06082102Beijing InnoCare Pharma Tech Co., Ltd.324