Diffuse Large B Cell Lymphoma
Conditions
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;
Interventions
DRUGChidamide + 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;
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results; 2. Age between 18 to 75 years old; 3. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2; 4. No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment; 5. Life expectancy no less than 6 months 6. The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures; 7. IPI mark\>1.
Exclusion criteria
1. History of autologous stem cell transplantation; 2. History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer; 3. With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases; 4. Lymphoma originated in the central nervous system; 5. Left ventricular ejection fraction ≦50％ 6. Abnormal lab results in enrollment: 1. Neutrophil count: \<1.5\*109/L； 2. Platelet count \<75\*109/L； 3. AST or ALT \>2 times the upper limit of normal level，AKP and total bilirubin \>1.5 times the upper limit of normal level; 4. serum creatinine \>1.5 times the upper limit of normal level; 7. Other uncontrolled medical conditions which the investigators think might influence the results of the trial; 8. Patients with mental illnesses or other diseases that might not comply with the trial plan; 9. Women during pregnancy or lactation; 10. HIV positive patients; 11. 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactWenbin Qian, MD. PhD.
Backup ContactHui Liu, MD. PhD
Outcome results
None listed