NCT07398638

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).

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_1

Timeline
57mo left

Started Feb 2026

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Feb 2026Feb 2031

First Submitted

Initial submission to the registry

January 28, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

February 28, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2031

Last Updated

February 10, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

January 28, 2026

Last Update Submit

February 7, 2026

Conditions

Diffuse Large B Cell Lymphoma (DLBCL)

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicity (DLT) for Phase 1b

    To identify the DLT

    The first cycle (each cycle is 21 days) after lisaftoclax administration.

  • Complete response rate (CRR) for Phase 2

    The proportion of patients who achieve complete response (CR)

    Up to 8 cycles (each cycle is 21 days)

Secondary Outcomes (4)

  • Overall response rate (ORR)

    Up to 8 cycles (each cycle is 21 days)

  • Duration of Response (DOR)

    Up to 5 years

  • Progression-free survival (PFS)

    Up to 5 years

  • Overall survival (OS)

    Up to 5 years

Study Arms (1)

Lisatoclax Combined with R-CHOP or Pola-R-CHP

EXPERIMENTAL

In Cohort 1, patients will receive standard-dose R-CHOP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with R-CHOP at the RP2D dose level for an extension study. In Cohort 2, patients will receive standard-dose Pola-R-CHP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with Pola-R-CHP at the RP2D dose level for an extension study.

Drug: R-CHOPDrug: POLA-R-CHPDrug: Lisaftoclax

Interventions

R-CHOPDRUG

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone

Lisatoclax Combined with R-CHOP or Pola-R-CHP
POLA-R-CHPDRUG

Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone

Lisatoclax Combined with R-CHOP or Pola-R-CHP
LisaftoclaxDRUG

Lisaftoclax (400 mg or 600 mg) is added from the second cycle of chemotherapy.

Lisatoclax Combined with R-CHOP or Pola-R-CHP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.
  • \. 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.
  • \. Age 18-70 years.
  • \. No prior systemic anti-lymphoma therapy.
  • \. Adequate organ and bone marrow function.
  • \. At least one measurable or evaluable disease site according to the Lugano 2014 lymphoma efficacy evaluation criteria.
  • \. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

You may not qualify if:

  • \. Lymphoma involvement in the central nervous system or meninges.
  • \. Active infections.
  • \. Uncontrolled clinical cardiac symptoms or diseases.
  • \. Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor.
  • \. Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
  • \. History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
  • \. Patients with mental disorders or those unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

R-CHOP protocolLisaftoclax

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Qingqing Cai, MD. PhD.

CONTACT

02087342823caiqq@sysucc.org.cn

Yi Xia, MD. PhD.

CONTACT

02087342823xiayi@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 10, 2026

Study Start

February 28, 2026

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2031

Last Updated

February 10, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)