Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Conditions
Brief summary
This is a single-arm, multi-center, open-label, phase 2 study to evaluate the efficacy and safety of ICP-248 in subjects with relapsed or refractory mantle cell lymphoma.
Interventions
DRUGICP-248
Eligible patients will receive ICP-248 orally as per the protocol
Sponsors
Beijing InnoCare Pharma Tech Co., 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
* ≥ 18 years old. * Histopathologically confirmed MCL expressing Cyclin D1 and/or t (11;14) chromosomal translocation.Formalin-fixed paraffin-embedded (FFPE) tissues or sections for diagnosis must be provided. It is for the approval of pathological diagnosis by the central pathology laboratory. * The patient was diagnosed with relapsed or refractory mantle cell lymphoma, and the previous treatment needs to meet the following requirements: * Failure of at least one adequate prior line of anti-CD20-containing therapy; * Failure of at least one adequate prior line of BTK inhibitor (BTKi)-containing therapy. * Failure of the last line of therapy. * At least one measurable lesion according to the Lugano 2014 criteria,. * ECOG performance status of 0-2 .
Exclusion criteria
* Blastoid or pleomorphic mantle cell lymphoma (MCL). * Current or prior history of central nervous system (CNS) lymphoma. * Prior use of BCL-2 inhibitors (e.g., venetoclax/ABT-199, etc.). * Autologous stem cell transplantation or cellular therapy within 3 months prior to the first dose of ICP-248. * Prior allogeneic hematopoietic stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) according to Lugano 2014 assessed by the independent review committee (IRC) | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| According to Lugano 2014: IRC and investigator assessed complete response rate (CRR) | 3 years |
| Investigator-assessed ORR | 3 years |
| According to Lugano 2014: IRC and investigator assessed disease control rate (DCR). | 3 years |
| According to Lugano 2014: IRC and investigator assessed duration of response (DOR). | 3 years |
| According to Lugano 2014: IRC and investigator assessed time to initial response (TTR). | 3 years |
| According to Lugano 2014: IRC and investigator assessed progression-free survival (PFS) . | 3 years |
| Overall survival (OS) | 3 years |
| Adverse event (AE) assessed according to CTCAE v5.0 criteria | 3 years |
| Functional Assessment Of Cancer Therapy-Lymphoma (Fact-Lym) and European Quality Of Life Five Dimension Five Level Scale Questionnaire (Eq-5D-5L). | 3 years |
| Area under the plasma concentration versus time curve (AUC) | 3 years |
| minimal residual disease （MRD） status | 3 years |
| Peak Plasma Concentration (Cmax) | 3 years |
| Time of maximum observed plasma(Tmax) | 3 years |
| Trough concentration(Ctrough) | 3 years |
| Apparent clearance (CL/F) | 3 years |
Countries
China
Contacts
Primary ContactAlexia Lu
Outcome results
None listed