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It's a prospective, single arm, open label phase II clinical trial, in which the safety and efficacy of Chidamide plus R-CHOP regimen is accessed in de novo DLBCL patients, who have received 2 courses of R-CHOP but only achieved PR or whose MRD tests for ctDNA revealed positive results.
abbreviation: R-CHOP: the chemo-therapy regimen composed of Rituximab, cyclophosphoamide, etoposide, vincristine and prednisone.
PR: partial remission; MRD:minimal residual disease;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | In this group, the patients will receive 2 courses of Chidamide+ R-CHOP regimen, the way of administration and dosage of the medicine used in the trial is as follows: Rituximab 375mg//m2, ivgtt,d1; CTX 750mg/m2, ivgtt,d2; EPI 70mg/m2, ivgtt,d2; VCR 1.4 mg/m2, ivgtt, d2; Pred 60 mg/m2, PO, d2-6; Chidamide 20mg/d,d1、4、8、11、14、18; one cycle every 21 days; abbreviation: CTX: cyclophosphamide;EPI:etoposide;VCR: vincristine;Pred:prednisone; R-CHOP:the chemo-therapy regimen composed of Rituximab, cyclophosphoamide; etoposide, vincristine and prednisone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide + R-CHOP regimen | Drug | Patients will receive 2 courses of Chidamide+ R-CHOP regimen, the way of administration and dosage of the medicine used in the trial is as follows: Rituximab 375mg//m2, ivgtt,d1;CTX 750mg/m2, ivgtt,d2;EPI 70mg/m2, ivgtt,d2;VCR 1.4 mg/m2, ivgtt, d2; Pred 60 mg/m2,PO, d2-6; Chidamide 20mg/d,d1、4、8、11、14、18;one cycle every 21 days; |
| Measure | Description | Time Frame |
|---|---|---|
| complete remission rate | complete remission rate after treated by Chidamide+ R-CHOP regimen | every 3 months until 30 months after the last patient's enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | from date of inclusion to date of progression, relapse, or death from any cause | from the day of treatment to the date of first documented progression,up to 30 months after the last patient's enrollment |
| overall survival |
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Inclusion Criteria:
Exclusion Criteria:
History of autologous stem cell transplantation;
History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer;
With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases;
Lymphoma originated in the central nervous system;
Left ventricular ejection fraction ≦50%
Abnormal lab results in enrollment:
Other uncontrolled medical conditions which the investigators think might influence the results of the trial;
Patients with mental illnesses or other diseases that might not comply with the trial plan;
Women during pregnancy or lactation;
HIV positive patients;
HbsAg (+) patients with HBV DNA(+), can be enrolled only when his/her HBV DNA turns negative; patients with HBsAg(-) HBcAb(+) can be enrolled only when his/her HBV DNA turns negative;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenbin Qian, MD. PhD. | Contact | (+86)13605801032 | qianwenb@aliyun.com | |
| Hui Liu, MD. PhD | Contact | (+86)13819198629 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
All the data would be available on the corresponding website of the leading research center.
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| C000613826 | HBI-8000 |
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|
|
from the date of inclusion to date of death, irrespective of cause
| 30 months after the last patient's enrollment |
| adverse events | any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure | from the date of first cycle of treatment to 30 months after last patient's enrollment |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |