Chidamide With R-CHOP Regimen for DLBCL Patients

NCT ID: NCT03201471

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-20
• Study Completion Date: 2020-02-05

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;

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Chidamide + R-CHOP regimen

Intervention Type: DRUG

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;

Interventions

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;

Intervention Type: DRUG

Other Intervention Names

HBI-8000

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Wenbin Qian

Chief of lymphoma center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The first affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenbin Qian, MD. PhD.

Role: CONTACT

qianwenb@aliyun.com

(+86)13605801032

Hui Liu, MD. PhD

Role: CONTACT

(+86)13819198629

Facility Contacts

Wenbin Qian, MD. PhD.

Role: primary

(+86)13605801032

Other Identifiers

lymphoma center Q001

Identifier Type: -

Identifier Source: org_study_id