NCT06778902

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
20mo left

Started Feb 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Feb 2025Jan 2028

First Submitted

Initial submission to the registry

January 7, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 16, 2025

Status Verified

December 1, 2024

Enrollment Period

2.9 years

First QC Date

January 7, 2025

Last Update Submit

January 12, 2025

Conditions

DLBCL - Diffuse Large B Cell Lymphoma

Keywords

Diffuse large B-cell lymphomaGemOxRAZA

Outcome Measures

Primary Outcomes (1)

  • Objective response rate(ORR)

    To investigate the preliminary anti-tumor efficacy

    Up to 8 cycles (each cycle is 21 days)

Secondary Outcomes (5)

  • Complete remission(CR)

    Up to 8 cycles (each cycle is 21 days)

  • Partial remission(PR)

    Up to 8 cycles (each cycle is 21 days)

  • Overall Survival (OS)

    From the date of enrollment until the date of death from ant cause, assessed up to 24 months

  • 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

  • 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

Other Outcomes (1)

  • The correlation of gene mutations and alterations in relevant signaling pathways with the efficacy and survival in DLBCL

    Through study completion, an average of 2 years

Study Arms (1)

AZA+GemOx

EXPERIMENTAL

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: azacytidineDrug: R-GemOx

Interventions

azacytidineDRUG

Azacytidine: 75mg/m2, d1-d5

AZA+GemOx
R-GemOxDRUG

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

AZA+GemOx

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chongqing, 400000, China

Location

MeSH Terms

Conditions

Dendritic Cell Sarcoma, InterdigitatingLymphoma, Large B-Cell, Diffuse

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Histiocytic Disorders, MalignantNeoplasms by Histologic TypeNeoplasmsHistiocytosisLymphatic DiseasesHemic and Lymphatic DiseasesLymphoma, B-CellLymphoma, Non-HodgkinLymphomaLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Central Study Contacts

Dongfeng Zeng, Pro

CONTACT

86+18680887505zengdf@tmmu.edu.cn

Fanqiao Meng

CONTACT

86+1339068175713396081757@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2025

First Posted

January 16, 2025

Study Start

February 1, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

January 16, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)