Evaluating Different Doses of Orelabrutinib in MCL

InnoCare Pharma

Status and phase: Enrolling; Phase 2

Conditions: Mantle Cell Lymphoma

Treatments: Drug: Orelabrutinib Low dose; Drug: Orelabrutinib High dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT05978739

ICP-CL-00127

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Orelabrutinib high dose

Experimental group

Treatment:

Drug: Orelabrutinib High dose

Orelabrutinib low dose

Experimental group

Treatment:

Drug: Orelabrutinib Low dose