AZA Combined with R-GemOx for Elderly DLBCL Patients

Phase 2

Not yet recruiting

• Conditions: DLBCL - Diffuse Large B Cell Lymphoma
• Interventions: Drug: azacytidine; Drug: R-GemOx

• Registration Number: NCT06778902
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief Summary

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of AZA（azacytidine）combined with the R-GemOx (rituximab, gemcitabine and oxaliplatin) regimen as first-line treatment in elderly diffuse large B-cell lymphoma (DLBCL) patients.

Detailed Description

The purpose of this phase II clinical trial is to evaluate the efficacy and safety of AZA in combination with R-GemOx for untreated elderly DLBCL patients.

The induction phase consisted of 8 cycles of AZA in combination with R-GemOx for a total of 8 treatment cycles. The efficacy was evaluated every 4 cycles, and if the efficacy was evaluated as complete remission (CR) or partial remission (PR), the original chemotherapy regimen was continued for 4 courses. If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.

The primary endpoint is the overall response rate (ORR).Secondary efficacy measures included CR and PR,SD, progression-free survival (PFS) and overall survival (OS).

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-12
• Last Update Submitted: 2025-01-12
• Study First Posted: 2025-01-16
• Last Update Posted: 2025-01-16
• Study Start: 2025-02-01
• Primary Completion: 2028-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Subjects fully understand and voluntarily participate in this study and sign informed consent.
2. Aged ≥60 years, both male and female.
3. Pathologically confirmed DLBCL
4. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
5. No previous chemotherapy or radiotherapy for DLBCL has been received.
6. Expected survival ≥3 months.

Key

Exclusion Criteria

1. DLBCL combined with other types of lymphoma. Transformed DLBCL.
2. DLBCL with central nervous system invasion.
3. The patients have contraindications to any drug in the combined treatment.
4. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
5. Mentally ill persons or persons unable to obtain informed consent.
6. The investigators think that the patient is not suitable for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZA+GemOx	azacytidine	Elderly DLBCL patients will receive AZA in combination with R-GemOx for a total of 8 treatment cycles (3 weeks per cycle). The efficacy was evaluated every 4 cycles, and if the efficacy was evaluated as complete remission (CR) or partial remission (PR), the original chemotherapy regimen was continued for 4 courses. If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.
AZA+GemOx	R-GemOx	Elderly DLBCL patients will receive AZA in combination with R-GemOx for a total of 8 treatment cycles (3 weeks per cycle). The efficacy was evaluated every 4 cycles, and if the efficacy was evaluated as complete remission (CR) or partial remission (PR), the original chemotherapy regimen was continued for 4 courses. If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.

Primary Outcome Measures

Name	Time	Method
Objective response rate(ORR)	Up to 8 cycles (each cycle is 21 days)	To investigate the preliminary anti-tumor efficacy

Secondary Outcome Measures

Name	Time	Method
Complete remission(CR)	Up to 8 cycles (each cycle is 21 days)	To investigate the preliminary anti-tumor efficacy
Partial remission(PR)	Up to 8 cycles (each cycle is 21 days)	To investigate the preliminary anti-tumor efficacy
Overall Survival (OS)	From the date of enrollment until the date of death from ant cause, assessed up to 24 months	To investigate the preliminary anti-tumor efficacy
Progression-free survival (PFS)	From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months	To investigate the preliminary anti-tumor efficacy
Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0	Through study completion, an average of 2 years	To identify the incidence of AE and SAE

Trial Locations

Locations (1)

Daping Hospital, Third Military Medical University (Army Medical University); 🇨🇳 Chongqing, China