Diffuse Large B Cell Lymphoma (DLBCL)
Conditions
Brief summary
This is a prospective, multicenter, open-label Phase Ib/II clinical study designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of lisatoclax in combination with R-CHOP or Pola-R-CHP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
Interventions
DRUGR-CHOP
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
DRUGPOLA-R-CHP
Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone
DRUGLisaftoclax
Lisaftoclax (400 mg or 600 mg) is added from the second cycle of chemotherapy.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures. * 2\. Diagnosed with DLBCL according to 2022 revised WHO lymphoma classification standards based on pathological diagnosis by the research center. For the dose-expansion phase, BCL-2 positivity (≥50% by IHC) is required. * 3\. Age 18-70 years. * 4\. No prior systemic anti-lymphoma therapy. * 5\. Adequate organ and bone marrow function. * 6\. At least one measurable or evaluable disease site according to the Lugano 2014 lymphoma efficacy evaluation criteria. * 7\. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion criteria
* 1\. Lymphoma involvement in the central nervous system or meninges. * 2\. Active infections. * 3\. Uncontrolled clinical cardiac symptoms or diseases. * 4\. Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor. * 5\. Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception. * 6\. History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS). * 7\. Patients with mental disorders or those unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) for Phase 1b | The first cycle (each cycle is 21 days) after lisaftoclax administration. | To identify the DLT |
| Complete response rate (CRR) for Phase 2 | Up to 8 cycles (each cycle is 21 days) | The proportion of patients who achieve complete response (CR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | Up to 8 cycles (each cycle is 21 days) | The proportion of patients who achieve complete response (CR) or partial response (PR) |
| Duration of Response (DOR) | Up to 5 years | To investigate the preliminary anti-tumor efficacy |
| Progression-free survival (PFS) | Up to 5 years | To investigate the preliminary anti-tumor efficacy |
| Overall survival (OS) | Up to 5 years | To investigate the preliminary anti-tumor efficacy |
Countries
China
Contacts
CONTACTQingqing Cai, MD. PhD.
CONTACTYi Xia, MD. PhD.
Outcome results
None listed