Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-02-01
2028-01-01
Brief Summary
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Detailed Description
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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 If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.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).
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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 If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.
azacytidine
Azacytidine: 75mg/m2, d1-d5
R-GemOx
Rituximab: 375mg/m2, d6; Gemcitabine: 1g/m2, d7 Oxaliplatin: 100mg/m2, d7
Interventions
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azacytidine
Azacytidine: 75mg/m2, d1-d5
R-GemOx
Rituximab: 375mg/m2, d6; Gemcitabine: 1g/m2, d7 Oxaliplatin: 100mg/m2, d7
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
60 Years
90 Years
ALL
No
Sponsors
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
OTHER
Responsible Party
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Locations
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Daping Hospital, Third Military Medical University (Army Medical University)
Chongqing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-322
Identifier Type: -
Identifier Source: org_study_id
ZXYZZKY07
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
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