Chidamide With R-CHOP Regimen for DLBCL Patients

Phase 2

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Drug: Chidamide + R-CHOP regimen

• Registration Number: NCT03201471
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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;

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-06-25
• Study First Posted: 2017-06-28
• Study Start: 2017-08-20
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02
• Primary Completion: 2019-12-30
• Study Completion: 2020-02-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	Chidamide + R-CHOP regimen	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
overall survival	30 months after the last patient's enrollment	from the date of inclusion to date of death, irrespective of cause
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

Trial Locations

Locations (1)

The first affiliated hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China