Chidamide With R-CHOP Regimen for DLBCL Patients

NCT03201471 | Unknown Phase 2 DMC

• 1 other identifier: lymphoma center Q001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• overall survival

  30 months after the last patient's enrollment

• adverse events

  from the date of first cycle of treatment to 30 months after last patient's enrollment

Study Arms (1)

treatment group

EXPERIMENTAL

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.

Drug: Chidamide + R-CHOP regimen

Interventions

Chidamide + R-CHOP regimen 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;

Also known as: HBI-8000

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results;
• Age between 18 to 75 years old;
• World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2;
• No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment;
• Life expectancy no less than 6 months
• The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures;
• IPI mark\>1.

You may not qualify if:

• History of autologous stem cell transplantation;
• History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer;
• With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases;
• Lymphoma originated in the central nervous system;
• Left ventricular ejection fraction ≦50％
• Abnormal lab results in enrollment:
• Neutrophil count: \<1.5\*109/L；
• Platelet count \<75\*109/L；
• AST or ALT \>2 times the upper limit of normal level，AKP and total bilirubin \>1.5 times the upper limit of normal level;
• serum creatinine \>1.5 times the upper limit of normal level;
• Other uncontrolled medical conditions which the investigators think might influence the results of the trial;
• Patients with mental illnesses or other diseases that might not comply with the trial plan;
• Women during pregnancy or lactation;
• HIV positive patients;
• 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;

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The first affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; HBI-8000

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Wenbin Qian, MD. PhD.

CONTACT

(+86)13605801032; qianwenb@aliyun.com

Hui Liu, MD. PhD

CONTACT

(+86)13819198629

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of lymphoma center

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 28, 2017
• Study Start: August 20, 2017
• Primary Completion: December 30, 2019
• Study Completion: February 5, 2020
• Last Updated: August 2, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)