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| ID | Type | Description | Link |
|---|---|---|---|
| ZXYZZKY07 | Other Grant/Funding Number | Army Medical Center Talent Innovation Ability Training Plan |
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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 If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| azacytidine | Drug | Azacytidine: 75mg/m2, d1-d5 |
| |
| R-GemOx |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | To investigate the preliminary anti-tumor efficacy | Up to 8 cycles (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission(CR) | To investigate the preliminary anti-tumor efficacy | Up to 8 cycles (each cycle is 21 days) |
| Partial remission(PR) | To investigate the preliminary anti-tumor efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| The correlation of gene mutations and alterations in relevant signaling pathways with the efficacy and survival in DLBCL | To explore the correlations between gene mutations and response and prognosis | Through study completion, an average of 2 years |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongfeng Zeng, Pro | Contact | 86+18680887505 | zengdf@tmmu.edu.cn | |
| Fanqiao Meng | Contact | 86+13390681757 | 13396081757@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daping Hospital, Third Military Medical University (Army Medical University) | Chongqing | 400000 | China |
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| ID | Term |
|---|---|
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015614 | Histiocytosis |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Drug |
Rituximab: 375mg/m2, d6; Gemcitabine: 1g/m2, d7 Oxaliplatin: 100mg/m2, d7 |
|
| Up to 8 cycles (each cycle is 21 days) |
| Overall Survival (OS) | To investigate the preliminary anti-tumor efficacy | From the date of enrollment until the date of death from ant cause, assessed up to 24 months |
| Progression-free survival (PFS) | To investigate the preliminary anti-tumor efficacy | 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 | To identify the incidence of AE and SAE | Through study completion, an average of 2 years |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |