Clinical trial NCT05978739: Evaluating Different Doses of Orelabrutinib in MCL
Official title: A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses of Orelabrutinib in Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Mantle Cell Lymphoma
Lead sponsor: InnoCare Pharma Inc.
Sponsor class: INDUSTRY
Collaborators: name: Beijing InnoCare Pharma Tech Co., Ltd.
First posted: 2023-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects ≥ 18 years of age.
2. Mantle cell lymphoma (MCL) confirmed by histopathology.
3. Subjects who have not previously received standard systemic care and relapsing/refractory subjects who have previously received standard systemic care.
4. At least one measurable lesion.
5. ECOG Physical fitness score 0-2 points.
6. Expected survival time ≥ 4 months.
7. Full hematology function.
8. Blood clotting function is basically normal.
9. Subjects with basically normal liver, kidney and heart function.
10. Subject voluntarily signs a written ICF.
11. The serum pregnancy test of female subjects with fertility potential was negative within 7 days before the first dosing.
12. 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.

Exclusion Criteria:

1. Adequate treatment with BTK inhibitors.
2. Have a history of severe allergic disease and a history of severe drug allergy.
3. Subjects who have received the treatment or drug restricted in the protocol within the time specified for the first use of the investigational drug.
4. 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.
5. History of other active malignant diseases within 2 years prior to screening.
6. Subjects with systemic bacterial, viral, fungal (other than nail fungal infections) or parasitic infections with poorly controlled activity.
7. Indicates active hepatitis B or C virus infection.
8. There are diseases that are excluded from the criteria in the programme.
9. Toxicity of previous anticancer therapy was still ≥ grade 2 at the start of study therapy (according to CTCAE V5.0).
10. History of severe bleeding disorder.
11. People with a known history of alcohol or drug abuse.
12. Subjects with mental disorders or poor compliance.
13. Pregnant or lactating female subjects.
14. Other conditions deemed unsuitable for participation in this study by the investigator.

Primary outcomes:
measure: Objective response rate（ORR）
timeFrame: Through study completion, an average of 2 year
Secondary outcomes:
measure: Complete Response Rate （CRR）
timeFrame: Through study completion, an average of 2 year
measure: Progression-Free Survival (PFS)
timeFrame: Through study completion, an average of 2 year
measure: Duration of Response (DoR)
timeFrame: Through study completion, an average of 2 year
measure: Maximum concentration (Cmax,ss)
timeFrame: Predose up to 24 hours postdose
measure: Time to maximum concentration (Tmax)
timeFrame: Predose up to 24 hours postdose
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: Predose up to 24 hours postdose
measure: Half-life (T1/2)
timeFrame: Predose up to 24 hours postdose
measure: Apparent clearance (CL/F)
timeFrame: Predose up to 24 hours postdose
measure: Adverse events（AEs）
timeFrame: Through study completion, an average of 2 year
measure: Serious adverse events （SAEs）
timeFrame: Through study completion, an average of 2 year
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Guangdong
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangzhou
city: Nanyang
country: China
facility: Nanyang Second General Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Chenzhou
country: China
facility: Chenzhou First People's Hospital
state: Hunan
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Urumqi
country: China
facility: The Affiliated Cancer Hospital of Xinjiang Medical University
state: Uygur Autonomous Region
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: