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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03268889
Other study ID # Jinzm 001
Secondary ID
Status Recruiting
Phase N/A
First received August 30, 2017
Last updated August 30, 2017
Start date June 15, 2017
Est. completion date September 15, 2020

Study information

Verified date August 2017
Source The First Affiliated Hospital of Soochow University
Contact Zhengming Jin, MD,PhD
Phone (+86)512-65223637
Email suzhouhematology@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL patients.


Description:

After enrollment, patients in this study will be given Chidamide, Cyclophosphamide, Epirubicin, Vincristine and Prednisone, and the efficacy and safety of this regimen are then evaluated.


Recruitment information / eligibility

Status Recruiting
Enrollment 39
Est. completion date September 15, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Pathologically diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2008 classification criteria(NK/T cell lymphoma, ALK positive anaplastic large cell lymphoma and granuloma fungoides excluded);

2. De novo peripheral T cell lymphoma patients;

3. Age 18-70 years old;

4. ECOG=2;

5. Female patients not in lactation nor pregnancy, and no intention to concept during the study and 12 months thereafter. Male patients agree not to impregnate his partner during the study and 12 months thereafter;

6. The patient should have evaluable foci (lymphnodes with diameter=1.0cm, or evaluable skin foci);

7. Willing to sign a written consent.

Exclusion Criteria:

1. T lymphoblast lymphoma;

2. Bone marrow infiltrated with lymphoma cell =25%;

3. NT/T cell lymphoma;

4. Granuloma fungoides;

5. Severe impaired liver/ renal function (ALT, Bilirubin or creatinine >3 times the normal maximum);

6. Uncontrolled infection;

7. Organic cardiopathy with clinical manifestation or impaired cardiac function (NYHA = level 2);

8. With other tumors;

9. With other condition that cause the patient unable to sign the written consent;

Study Design


Intervention

Drug:
Chidamide
Chidamide is given to the patients in this study along with CHOP regimen, to access the efficacy and safety in this cohort of PTCL patients. The dosage of the above regimen is as follows: Chidamide, 30mg,po,biw; Cyclophosphamide 750mg/m2, ivgtt, d1; Epirubicin 70mg/ m2, ivgtt, d1; Vincristine 3mg/ m2, ivgtt, d1; Prednisone 100mg/ m2, po, d1-5.

Locations

Country Name City State
China the First Affiliated Hospital of Soochow University Suzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete Remission Rate the rate of patients who achieve complete remission after the treatment 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 duration of remission from date of complete remission 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
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