Clinical trial NCT03201471: Chidamide With R-CHOP Regimen for DLBCL Patients
Official title: Chidamide With R-CHOP Regimen for de Novo, High Risk Diffuse Large B Cell Lymphoma (DLBCL): A Prospective, Signal Arm, Open Label Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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;


Eligibility criteria: 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;

Primary outcomes:
measure: complete remission rate
timeFrame: every 3 months until 30 months after the last patient's enrollment
Secondary outcomes:
measure: progression free survival
timeFrame: from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment
measure: overall survival
timeFrame: 30 months after the last patient's enrollment
measure: adverse events
timeFrame: from the date of first cycle of treatment to 30 months after last patient's enrollment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The first affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
References: