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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.
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 If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.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).
Age
60 - 90 years
Sex
ALL
Healthy Volunteers
No
Daping Hospital, Third Military Medical University (Army Medical University)
Chongqing, China
Start Date
February 1, 2025
Primary Completion Date
January 1, 2028
Completion Date
January 1, 2028
Last Updated
January 16, 2025
80
ESTIMATED participants
azacytidine
DRUG
R-GemOx
DRUG
Lead Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06026488