NCT07398638Not yet recruitingPhase 1/2
Lisatoclax Plus R-CHOP or Pola-R-CHP in Untreated DLBCL: A Phase Ib/II Study
A Phase Ib/II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Lisatoclax in Combination With R-CHOP or Pola-R-CHP in Patients With Previously Untreated DLBCL
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- First submitted
- 28 Jan 2026
- Start date
- 28 Feb 2026
- Primary completion date
- 28 Feb 2029
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT07398638
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 122
- From 28 Feb 2026 to the primary completion date, 28 Feb 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 4\. Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor.
Other illness
- 2\. Active infections.
- 3\. Uncontrolled clinical cardiac symptoms or diseases.
- 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
Age
- 5\. Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
Other
- 1\. Lymphoma involvement in the central nervous system or meninges.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.