AZA Combined with R-GemOx for Elderly DLBCL Patients (Dragon)

January 12, 2025 updated by: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.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

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Chongqing, China, 400000
        • Daping Hospital, Third Military Medical University (Army Medical University)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZA+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.
Drug: azacytidine
Azacytidine: 75mg/m2, d1-d5
Drug: R-GemOx
Rituximab: 375mg/m2, d6; Gemcitabine: 1g/m2, d7 Oxaliplatin: 100mg/m2, d7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate(ORR)
Time Frame: Up to 8 cycles (each cycle is 21 days)
To investigate the preliminary anti-tumor efficacy
Up to 8 cycles (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
To investigate the preliminary anti-tumor efficacy
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
To identify the incidence of AE and SAE
Through study completion, an average of 2 years
Complete remission(CR)
Time Frame: Up to 8 cycles (each cycle is 21 days)
To investigate the preliminary anti-tumor efficacy
Up to 8 cycles (each cycle is 21 days)
Partial remission(PR)
Time Frame: Up to 8 cycles (each cycle is 21 days)
To investigate the preliminary anti-tumor efficacy
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
To investigate the preliminary anti-tumor efficacy
From the date of enrollment until the date of death from ant cause, assessed up to 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation of gene mutations and alterations in relevant signaling pathways with the efficacy and survival in DLBCL
Time Frame: Through study completion, an average of 2 years
To explore the correlations between gene mutations and response and prognosis
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 12, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-322
  • ZXYZZKY07 (Other Grant/Funding Number: Army Medical Center Talent Innovation Ability Training Plan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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