Mantle Cell Lymphoma (MCL)
Conditions
Brief summary
This is an open-label, single arm, multi-center Phase 2 study of oral Rocbrutinib in patients with mantle cell lymphoma who are failed or relapsed after remission or intolerated to Bruton's tyrosine kinase (BTK) inhibitor.
Interventions
DRUGRocbrutinib
Subjects to take Rocbrutinib tablets orally with 240mL water, without food, Once daily.The treatment will continue until progressive disease, unacceptable toxicity, etc.
Sponsors
Guangzhou Lupeng Pharmaceutical Company LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Per 2017 revised WHO lymphoma classification criteria, subject must have diagnosed with MCL. 2. At least one measurable lesion. 3. Subjects who have previously received the treatment regimen containing anti-CD20 and at least one BTKi treatment failed or relapsed after remission or intolerated; Or Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated, and are not suitable for treatment with anti-CD20. 4. ECOG≤2. 5. Adequate hematologic function. 6. Adequate hepatic and renal function. 7. Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal \[and 2 years of non-therapy-induced amenorrhea\] or surgically sterile) to observe conventional and effective birth control.
Exclusion criteria
1. Received non-covalent BTK inhibitor treatment. 2. Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of Rocbrutinib: Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy. 3. Subjects who have received the following treatments within 2 weeks before the first dose of Rocbrutinib: Steroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia. 4. Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections. 5. Disease affects the central nervous system. 6. Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | Up to 24 Months | To assess the anti-tumor activity of Rocbrutinib based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission rate | Up to 24 Months | To assess the preliminary anti-tumor activity of Rocbrutinib based on complete remission rate (CR) as assessed by investigator and IRC. |
| Progression Free Survival | Measured from the date of first dose of study drug to the date of earliest disease progression or death or last visit, and assessed up to 24 months. | To assess the preliminary anti-tumor activity of Rocbrutinib based on Progression Free Survival (PFS) as assessed by investigator and IRC. |
| Overall survival | Measured from the date of date of first dose to the date of death or last visit, and for up to 5 years after the last subject is enrolled. | To assess the preliminary anti-tumor activity of Rocbrutinib based on Overall survival (OS) as assessed by investigator and IRC. |
| Duration of Response (DOR) | Measured from the date of the first remission to the date of earliest disease progression or death, and assessed up to 24 months. | To assess the preliminary anti-tumor activity of Rocbrutinib based on Duration of response (DOR) as assessed by the Investigator and IRC. |
| Time to Response (TTR) | Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months. | To assess the preliminary anti-tumor activity of Rocbrutinib based on Time to response (TTR) as assessed by the Investigator and IRC. |
| Overall Response Rate | Up to 24 Months | To assess the anti-tumor activity of Rocbrutinib based on overall response rate (ORR) as assessed by investigator. |
| Maximum Observed Plasma Concentration (Cmax) | Up to 24 hours post dose | Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of Rocbrutinib |
| Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) | Up to 24 hours post dose | PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) of Rocbrutinib |
| Maximum Observed Plasma Concentration (Tmax) | Up to 24 hours post dose | PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of Rocbrutinib |
| Half-life period (T1/2) | Up to 24 hours post dose | PK As Assessed By Time To Half-life period (T1/2) Of Rocbrutinib |
| Quality of life (QoL) | Up to 24 Months | Quality of life Assessed By the European Organization for Research and Treatment of Cancer core quality of life (EORTC QLQ-C30) questionnaire (The total score ranges from 30 to126, Items 29 and 30 are scored from 1 to 7 points, and other items are scored from 1 to 4 points. Except for items 29 and 30, the higher value, the worse QoL.) |
| Safety Assessment | From first dose of study drug to 28 days after last dose of study drug | To evaluate the safety of Rocbrutinib by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0 |
Countries
China
Outcome results
None listed