Mantle Cell Lymphoma
Conditions
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.
Interventions
DRUGOrelabrutinib High dose
Orelabrutinib will be administered as 3 tablets once per day
DRUGOrelabrutinib Low dose
Orelabrutinib will be administered as 1 tablet once per day
Sponsors
InnoCare Pharma Inc.
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 | — |
| 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 | — |
| Half-life (T1/2) | Predose up to 24 hours postdose | — |
| Apparent clearance (CL/F) | Predose up to 24 hours postdose | — |
| Adverse events（AEs） | Through study completion, an average of 2 year | — |
| Serious adverse events （SAEs） | Through study completion, an average of 2 year | — |
Countries
China
Outcome results
None listed