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NCT Number: NCT06778902

AZA Combined with R-GemOx for Elderly DLBCL Patients

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.

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Key information

Conditions

DLBCL - Diffuse Large B Cell Lymphoma Dendritic Cell Sarcoma, Interdigitating Hemic and Lymphatic Diseases Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Daping Hospital, Third Military Medical University (Army Medical University)

Chongqing, 400000, China

About this study

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 If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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.

Key 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.

Treatment and study plan

Azacytidine

Drug

Azacytidine: 75mg/m2, d1-d5

R-GemOx

Drug

Rituximab: 375mg/m2, d6; Gemcitabine: 1g/m2, d7 Oxaliplatin: 100mg/m2, d7

Primary outcomes

  1. Objective response rate(ORR)

    Time frame: Up to 8 cycles (each cycle is 21 days)

    To investigate the preliminary anti-tumor efficacy

Secondary outcomes

  1. Complete remission(CR)

    Time frame: Up to 8 cycles (each cycle is 21 days)

    To investigate the preliminary anti-tumor efficacy

  2. Partial remission(PR)

    Time frame: Up to 8 cycles (each cycle is 21 days)

    To investigate the preliminary anti-tumor efficacy

  3. 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

  4. 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

  5. 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

Other outcomes

  1. 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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: Dragon

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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