Chidamide With R-CHOP Regimen for DLBCL Patients

Diffuse Large B Cell Lymphoma Clinical Trial

— DLBCL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03201471
• Other study ID #: lymphoma center Q001
• Status: Recruiting
• Phase: Phase 2
• Start date: August 20, 2017
• Est. completion date: February 5, 2020

Study information

• Verified date: August 2018
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Wenbin Qian, MD. PhD.
• Phone: (+86)13605801032
• Email: qianwenb[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: February 5, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

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;

Locations

Country	Name	City	State
China	The first affiliated hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	overall survival	from the date of inclusion to date of death, irrespective of cause	30 months after the last patient's enrollment
Secondary	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