Clinical trial · Interventional
AZA Combined with R-GemOx for Elderly DLBCL Patients
AZA Combined with R-GemOx for the Initial Treatment of Elderly DLBCL: an Open, Single-arm, Multicenter Clinical Study
NCT06778902CI-TRIAL-00084793Dragonnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DLBCL - Diffuse Large B Cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| azacytidine | Drug | Azacitidine | ALIAS |
| R-GemOx | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AZA+GemOx
- description
- 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 If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.
- interventionNames
- Drug: azacytidine
- Drug: R-GemOx
Primary outcomes (1)
- measure
- Objective response rate(ORR)
- timeFrame
- Up to 8 cycles (each cycle is 21 days)
- description
- To investigate the preliminary anti-tumor efficacy
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.