Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Conditions
Brief summary
This study aims to compare the efficacy and safety of ICP-248 in combination with orelabrutinib versus pirtobrutinib in patients with relapsed or refractory mantle cell lymphoma (r/r MCL).
Interventions
DRUGICP-248
Administered orally
DRUGPirtobrutinib
Administered orally
DRUGOrelabrutinib
Administered orally
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. Known intolerance to orelabrutinib or pirtobrutinib treatment. 2. Received autologous hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the investigational product. Received allogeneic hematopoietic stem cell transplantation at any time in the past. 3. Patients with other malignancies within 2 years prior to enrollment. 4. Uncontrolled or significant cardiovascular disease. 5. Hemophilia A, Hemophilia B, von Willebrand disease history or requiring the use of warfarin or equivalent vitamin K antagonist anticoagulants (such as phenprocoumon, etc.) or assessed by the investigator to have a tendency for spontaneous bleeding. 6. Participants with severe central nervous system diseases. 7. Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy. 8. Underwent major surgery within 4 weeks prior to the first dose. 9. Active infections require systemic treatment. 10. Active autoimmune diseases. 11. Known central nervous system lymphoma. 12. Known alcohol or drug dependence.
Exclusion criteria
1. Known intolerance to orelabrutinib or pirtobrutinib treatment. 2. Received autologous hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the investigational product. Received allogeneic hematopoietic stem cell transplantation at any time in the past. 3. Patients with other malignancies within 2 years prior to enrollment. 4. Uncontrolled or significant cardiovascular disease. 5. Hemophilia A, Hemophilia B, von Willebrand disease history or requiring the use of warfarin or equivalent vitamin K antagonist anticoagulants (such as phenprocoumon, etc.) or assessed by the investigator to have a tendency for spontaneous bleeding. 6. Participants with severe central nervous system diseases. 7. Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy. 8. Underwent major surgery within 4 weeks prior to the first dose. 9. Active infections require systemic treatment. 10. Active autoimmune diseases. 11. Known central nervous system lymphoma. 12. Known alcohol or drug dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) as assessed by Independent Review Committee (IRC). | 6 years |
Secondary
| Measure | Time frame |
|---|---|
| Investigator-assessed PFS according to Lugano 2014. | 6 years |
| IRC-assessed and investigators-assessed overall response rate (ORR) according to Lugano 2014 | 6 years |
| IRC-assessed and investigators-assessed complete response rate (CRR) according to Lugano 2014 | 6 years |
| IRC-assessed and investigators-assessed duration of response (DOR) according to Lugano 2014 | 6 years |
| IRC-assessed and investigators-assessed time to first response (TTR) according to Lugano 2014 | 6 years |
| Time to next treatment (TTNT) | 6 years |
| Overall Survival (OS) | 6 years |
| Eastern Cooperative Oncology Group (ECOG) performance status | 6 years |
Countries
China
Contacts
CONTACTAlexia Lu
Outcome results
None listed