- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03201471
Chidamide With R-CHOP Regimen for DLBCL Patients (DLBCL)
Chidamide With R-CHOP Regimen for de Novo, High Risk Diffuse Large B Cell Lymphoma (DLBCL): A Prospective, Signal Arm, Open Label Clinical Trial
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;
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Wenbin Qian, MD. PhD.
- Phone Number: (+86)13605801032
- Email: qianwenb@aliyun.com
Study Contact Backup
- Name: Hui Liu, MD. PhD
- Phone Number: (+86)13819198629
Study Locations
-
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Recruiting
- The First Affiliated Hospital of Zhejiang University
-
Contact:
- Wenbin Qian, MD. PhD.
- Phone Number: (+86)13605801032
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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;
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complete remission rate
Time Frame: every 3 months until 30 months after the last patient's enrollment
|
complete remission rate after treated by Chidamide+ R-CHOP regimen
|
every 3 months until 30 months after the last patient's enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression free survival
Time Frame: 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
|
from the day of treatment to the date of first documented progression,up to 30 months after the last patient's enrollment
|
overall survival
Time Frame: 30 months after the last patient's enrollment
|
from the date of inclusion to date of death, irrespective of cause
|
30 months after the last patient's enrollment
|
adverse events
Time Frame: 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
|
from the date of first cycle of treatment to 30 months after last patient's enrollment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- lymphoma center Q001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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