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Phase Ib/II Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide in Newly Diagnosed Elderly Patients With Double-Expressor DLBCL

Phase 2Not Yet RecruitingNCT07415980
Sun Yat-sen University68 enrolled

Overview

This is a single-arm, prospective, multicenter, open-label phase Ib/II study to evaluate the safety and efficacy of polatuzumab vedotin in combination with rituximab and chidamide in previously untreated elderly patients with MYC/BCL2 double-expressor diffuse large B-cell lymphoma.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

68

Conditions

Double Expressor DLBCL

Interventions

Polatuzumab VedotinDRUG

1.8 mg/kg intravenously on Day 1 of each 21-day cycle.

Rituximab (R)DRUG

375 mg/m² intravenously once weekly during Cycle 1, followed by administration on Day 1 of each subsequent cycle.

ChidamideDRUG

20 mg, po, biw

Eligibility

Sex: ALLMin age: 60 Years
Medical Language ↔ Plain English
Inclusion Criteria: * 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; * Age ≥70 years, or age 60-69 years with frailty determined by comprehensive geriatric assessment (CGA). * Pathologically confirmed diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) with MYC/BCL2 double expression, and no double-hit or triple-hit lymphoma. * At least one measurable or evaluable lesion according to the Lugano 2014 criteria. * No prior systemic therapy for DLBCL. * Adequate organ and bone marrow function. Exclusion Criteria: * Other subtypes of DLBCL. * Lymphoma involvement in the central nervous system or meninges. * Active infections. * History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS). * Patients with mental disorders or those unable to provide informed consent * Any other condition deemed by the investigator to be unsuitable for study enrollment. * Known hypersensitivity to any investigational drug.

Outcomes

Primary Outcomes

DLT for Phase 1b

To identify the dose-limiting toxicity

Time frame: The first cycle after administration (each cycle is 21 days)

RP2D for phase Ib

To identify the recommended phase 2 dose

Time frame: The first cycle after administration (each cycle is 21 days)

Complete response rate (CRR) for Phase 2

The proportion of patients who achieve complete remission (CR).

Time frame: Up to 6 cycles (every cycle is 21 days)

Secondary Outcomes

Overall response rate (ORR)

The proportion of patients who achieve complete response (CR) or partial response (PR).

Time frame: Up to 6 cycles (every cycle is 21 days)

Duration of Response (DOR)

To investigate the preliminary anti-tumor efficacy

Time frame: Up to 5 years

Progression-free survival (PFS)

To investigate the preliminary anti-tumor efficacy

Time frame: Up to 5 years

Overall survival (OS)

To investigate the preliminary anti-tumor efficacy

Time frame: Up to 5 years

Central Contacts

Qingqing Cai, MD. PhD.

CONTACT

+8602087342823caiqq@sysucc.org.cn
Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.