Relapsed/Refractory Marginal Zone Lymphoma (MZL)
Conditions
Brief summary
To evaluate the efficacy of olubrutinib combined with ICP-248 compared with the olubrutinib in the treatment of r/r MZL
Detailed description
This is an open label, randomized, multicenter phase 3 study for adult participants with relapsed/refractory marginal zone lymphoma (R/R MZL). The main goals are to compare complete response rate (CRR) and progression free survival (PFS) between the two treatment groups assessed by an Independent Review Committee (IRC).
Interventions
DRUGOrelabrutinib
Participants receive orelabrutinib 150 mg oral once daily continuous dosing; each cycle is 28 days.
DRUGICP-248
Eligible patients will receive ICP-248 orally as per the protocol
Sponsors
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. Aged ≥18 years, male or female. 2. Histopathologically confirmed marginal zone lymphoma (including splenic, nodal, extranodal MZL subtypes). 3. Has received at least one prior line of systemic therapy containing anti CD20 monoclonal antibody. 4. Disease is relapsed or refractory. 5. Has measurable disease per 2014 Lugano classification. 6. Meets required laboratory thresholds for hematological, liver, and renal function 7. Females must have negative serum pregnancy test. Participants must use effective contraception during the study. 8. Able to comply with study procedures and assessments. 9. Voluntarily provides written informed consent.
Exclusion criteria
1. Confirmed transformation into an aggressive lymphoma. 2. Received anti cancer therapies within 2 weeks before first investigational product dose. 3. Chronic corticosteroid for anti cancer purpose during screening. 4. Any investigational agent within 4 weeks before study treatment; concurrent participation in other investigational therapeutic trials. 5. Prior disease refractory to BTK inhibitor or BCL 2 inhibitor treatment. 6. Prior allogeneic hematopoietic stem cell transplantation or CAR T therapy. 7. central nervous system / meningeal lymphoma involvement. 8. Second primary malignancy within 2 years before screening. 9. Uncontrolled clinically significant cardiovascular disease. 10. Thromboembolic events within 6 months prior to first dose. 11. Grade 3 4 active bleeding within 2 months before screening or significant bleeding diathesis. 12. Clinically significant gastrointestinal malabsorption, major gastrointestinal resection. 13. Major surgery or severe trauma before first dose or planned selective surgery during study. 14. Active infection requiring intravenous anti infective therapy; positive HIV antibody; active HBV/HCV. 15. Severe interstitial lung disease, pneumoconiosis, radiation or drug induced pneumonitis. 16. Active autoimmune disease requiring systemic therapy. 17. Psychiatric/cognitive disorders. 18. Substance abuse. 19. Use of strong CYP3A/P gp inhibitors / inducers within 5 drug half lives before dosing or planned concomitant intake of strong modulating agents/food during study. 20. Received live / live attenuated vaccines within 4 weeks prior to first study drug dose. 21. Known severe hypersensitivity/anaphylaxis to investigational products, drug class agents or tablet excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate (CRR) assessed by Independent Review Committee (IRC) | Approximately 3 years. |
| Progression Free Survival (PFS) assessed by Independent Review Committee (IRC) | Approximately 5 years. |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) and Overall Survival (OS) | Approximately 5 years. |
| Duration of response (DoR), time to response (TTR) | Approximately 5 years. |
| Safety endpoints include adverse events (AEs) | Approximately 5 years. |
Countries
China
Contacts
CONTACTJingnan Yang
Outcome results
None listed