Status:
UNKNOWN
Evaluating Different Doses of Orelabrutinib in MCL
Lead Sponsor:
InnoCare Pharma Inc.
Collaborating Sponsors:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 25 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05978739
Start Date
August 18 2023
End Date
May 25 2025
Last Update
October 25 2023
Active Locations (20)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233040
2
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
4
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030