Chidamide With R-CHOP Regimen for DLBCL Patients
Study Details
Study Description
Brief Summary
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;
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: treatment group 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. |
Drug: Chidamide + R-CHOP regimen
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;
Other Names:
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Outcome Measures
Primary Outcome Measures
- complete remission rate [every 3 months until 30 months after the last patient's enrollment]
complete remission rate after treated by Chidamide+ R-CHOP regimen
Secondary Outcome Measures
- progression free survival [from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment]
from date of inclusion to date of progression, relapse, or death from any cause
- overall survival [30 months after the last patient's enrollment]
from the date of inclusion to date of death, irrespective of cause
- adverse events [from the date of first cycle of treatment to 30 months after last patient's enrollment]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results;
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Age between 18 to 75 years old;
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World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2;
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No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment;
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Life expectancy no less than 6 months
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The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures;
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IPI mark>1.
Exclusion Criteria:
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History of autologous stem cell transplantation;
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History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer;
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With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases;
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Lymphoma originated in the central nervous system;
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Left ventricular ejection fraction ≦50％
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Abnormal lab results in enrollment:
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Neutrophil count: <1.5*109/L；
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Platelet count <75*109/L；
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AST or ALT >2 times the upper limit of normal level，AKP and total bilirubin >1.5 times the upper limit of normal level;
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serum creatinine >1.5 times the upper limit of normal level;
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Other uncontrolled medical conditions which the investigators think might influence the results of the trial;
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Patients with mental illnesses or other diseases that might not comply with the trial plan;
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Women during pregnancy or lactation;
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HIV positive patients;
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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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The first affiliated hospital of Zhejiang University | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- First Affiliated Hospital of Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- lymphoma center Q001