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This is a prospective, observational, multicenter, cohort study with 400 newly treated DLBCL patients. To evaluate the clinical efficacy and safety of tucidinostat in the real-world treatment of primary diffuse large B-cell lymphoma
The study was divided into 2 cohorts. Cohort 1: DLBCL patients diagnosed unfit/ Unfit. A person who is unfit/ unfit is defined as being 80 years or older, or younger than 80 years old but has comorbidities and cannot tolerate a standard dose of chemotherapy as determined by the investigator. Reference options for a combination regimen include C-R2, C-R-mini-CHOP, etc.
Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit. Reference options for a combination regimen include CR-CHOP, C-Pola-R-CHP, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: DLBCL patients diagnosed unfit/ Unfit. | A person who is unfit/ unfit is defined as being 80 years or older, or younger than 80 years old but has comorbidities and cannot tolerate a standard dose of chemotherapy as determined by the investigator. |
| |
| Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit. | Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity treatment options | Drug | Reference options for a combined regimen include C-R2, C-R-mini-CHOP, etc. Subjects whose efficacy is assessed as CR after the end of induction therapy will enter consolidation therapy. Tucidinostat maintenance therapy or autologous hematopoietic stem cell transplantation may be an option. Tucidinostat maintenance therapy will be performed every 3 weeks. .Single-drug maintenance is recommended to last 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| EFS(Event-free survival) | The length of time from the start of treatment to the onset of disease progression, recurrence after CR, death from any cause, or the start of new therapy for residual lesions (including conversion therapy for lesions during the trial) after the end of combination therapy, whichever occurs first. | 2-year |
| Measure | Description | Time Frame |
|---|---|---|
| CRR(Complete response rate) | The number of subjects who achieved complete response (CR) at the end of combination therapy as a percentage of the total number of participants in the analysis. | End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] |
| PFS(Progression-free survival) |
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Inclusion Criteria:
1. Age ≥18 years old, male or female;
2. No previous treatment for DLBCL, including chemotherapy, targeted therapy and immunotherapy;
3. DEL [Diffuse large B-cell lymphoma with double expression of MYC and BCL2 (immunohistochemical MYC≥40%, BCL2≥50%)] was confirmed by pathology; Or non-double expression but at least one of the following:;
4. Plan to receive or are receiving a treatment regimen containing tucidinostat (if it is permitted to start using tucidinostat after obtaining specific test results due to pending genetic sequencing results);
5. Voluntarily sign informed consent.
Exclusion Criteria:
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400
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengpeng Xu, professor | Contact | 13564015001 | pengpeng_xu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No. 197 Ruijin 2nd Road, Huangpu District, Shanghai | Recruiting | Shanghai | Shanghai Municipality | China |
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| Conventional immunochemotherapy regimen | Drug | Reference options for a combined regimen include CR-CHOP, C-Pola-R-CHP, etc. Subjects whose efficacy is assessed as CR after the end of induction therapy will enter consolidation therapy. Tucidinostat maintenance therapy or autologous hematopoietic stem cell transplantation may be an option. Tucidinostat maintenance therapy will be performed every 3 weeks. Single-drug maintenance is recommended to last 24 weeks |
|
The length of time from the start of treatment to the onset of disease progression or recurrence or death from any cause, whichever occurs first |
| 2-year |
| OS(Overall survival) | From the start of treatment to the time of death from any cause. | 2-year |