AZA Combined with R-GemOx for Elderly DLBCL Patients

Official title

AZA Combined with R-GemOx for the Initial Treatment of Elderly DLBCL: an Open, Single-arm, Multicenter Clinical Study

Overview

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 If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.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).

Interventions

• Drug azacytidine
  Azacytidine: 75mg/m2, d1-d5
• Drug R-GemOx
  Rituximab: 375mg/m2, d6; Gemcitabine: 1g/m2, d7 Oxaliplatin: 100mg/m2, d7

Primary outcome measures

• Objective response rate(ORR) [Time frame: Up to 8 cycles (each cycle is 21 days)]

Secondary outcome measures (5)

• Complete remission(CR) [Time frame: Up to 8 cycles (each cycle is 21 days)]
• Partial remission(PR) [Time frame: Up to 8 cycles (each cycle is 21 days)]
• Overall Survival (OS) [Time frame: From the date of enrollment until the date of death from ant cause, assessed up to 24 months]
• Progression-free survival (PFS) [Time frame: 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]
• Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0 [Time frame: Through study completion, an average of 2 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Daping Hospital, Third Military Medical University (Army Medical University) — Chongqing

Identifiers

NCT: NCT06778902 · 2024-322 · ZXYZZKY07

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗