Chidamide With CHOP Regimen for de Novo PTCL Patients (CHOP: Cyclophosphamide, Etoposide, Vincristine and Prednisone; PTCL: Peripheral T Cell Lymphoma)

Peripheral T Cell Lymphoma Clinical Trial

— CHOP  

Official title:

Chidamide With Cyclophosphamide, Etoposide, Vincristine and Prednisone for de Novo Peripheral T Cell Lymphoma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03268889
• Other study ID #: Jinzm 001
• 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
• 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;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T Cell Lymphoma

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