Evaluating Different Doses of Orelabrutinib in MCL
- Conditions
- Mantle Cell Lymphoma
- Interventions
- Registration Number
- NCT05978739
- Lead Sponsor
- InnoCare Pharma Inc.
- Brief Summary
This is A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses of Orelabrutinib in Mantle Cell Lymphoma to Evaluate the Efficacy and Safety in Mantle Cell Lymphoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Male and female subjects ≥ 18 years of age.
- Mantle cell lymphoma (MCL) confirmed by histopathology.
- Subjects who have not previously received standard systemic care and relapsing/refractory subjects who have previously received standard systemic care.
- At least one measurable lesion.
- ECOG Physical fitness score 0-2 points.
- Expected survival time ≥ 4 months.
- Full hematology function.
- Blood clotting function is basically normal.
- Subjects with basically normal liver, kidney and heart function.
- Subject voluntarily signs a written ICF.
- The serum pregnancy test of female subjects with fertility potential was negative within 7 days before the first dosing.
- Female subjects with reproductive potential or male subjects and their partners must agree to use effective contraception for at least 6 months from signing the ICF until the last dose of the study drug.
- Adequate treatment with BTK inhibitors.
- Have a history of severe allergic disease and a history of severe drug allergy.
- Subjects who have received the treatment or drug restricted in the protocol within the time specified for the first use of the investigational drug.
- The last use of a potent CYP3A inhibitor or potent CYP3A inducer (including food, western medicine, and Chinese medicine) was less than 2 weeks (or less than 5 half-lives, depending on the time) from the first trial, or plan to take a potent CYP3A inhibitor or potent CYP3A inducer drug or food during the study period.
- History of other active malignant diseases within 2 years prior to screening.
- Subjects with systemic bacterial, viral, fungal (other than nail fungal infections) or parasitic infections with poorly controlled activity.
- Indicates active hepatitis B or C virus infection.
- There are diseases that are excluded from the criteria in the programme.
- Toxicity of previous anticancer therapy was still ≥ grade 2 at the start of study therapy (according to CTCAE V5.0).
- History of severe bleeding disorder.
- People with a known history of alcohol or drug abuse.
- Subjects with mental disorders or poor compliance.
- Pregnant or lactating female subjects.
- Other conditions deemed unsuitable for participation in this study by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orelabrutinib high dose Orelabrutinib High dose - Orelabrutinib low dose Orelabrutinib Low dose -
- Primary Outcome Measures
Name Time Method Objective response rate（ORR） Through study completion, an average of 2 year Proportion of subjects with tumor response of Complete Response（CR） or Partial Response（PR） after treatment in total subjects.
- Secondary Outcome Measures
Name Time Method Complete Response Rate （CRR） Through study completion, an average of 2 year The proportion of subjects with tumor response of Complete Response（CR） after treatment in total subjects.
Duration of Response (DoR) Through study completion, an average of 2 year The time from documentation of objective response to the first occurrence of tumor progression or death due to any cause, whichever occurs first.
Maximum concentration (Cmax,ss) Predose up to 24 hours postdose Adverse events（AEs） Through study completion, an average of 2 year Progression-Free Survival (PFS) Through study completion, an average of 2 year From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Half-life (T1/2) Predose up to 24 hours postdose Time to maximum concentration (Tmax) Predose up to 24 hours postdose Area under the plasma concentration-time curve (AUC) Predose up to 24 hours postdose Apparent clearance (CL/F) Predose up to 24 hours postdose Serious adverse events （SAEs） Through study completion, an average of 2 year
Trial Locations
- Locations (20)
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Sun Yat-sen University Cancer Center
🇨🇳Guangdong, Guangzhou, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Nanyang Second General Hospital
🇨🇳Nanyang, Henan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
The Second Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The First Affiliated Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
The Affiliated Cancer Hospital of Xinjiang Medical University
🇨🇳Urumqi, Uygur Autonomous Region, China
The First Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Chenzhou First People's Hospital
🇨🇳Chenzhou, Hunan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China