Lisatoclax Plus R-CHOP or Pola-R-CHP in Untreated DLBCL: A Phase Ib/II Study
Starting soon · Phase 1/Phase 2
Conditions studied: Diffuse Large B Cell Lymphoma (DLBCL)
In brief
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).
Key facts
- Study ID
- NCT07398638
- Run by
- Sun Yat-sen University
- People needed
- 122
- Starts
- 2026-02-28
- Expected to finish
- 2031-02-28
- Last updated by the study team
- 2026-02-10
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
Full record on ClinicalTrials.gov
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