Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University
• Collaborators: Jiangxi Provincial Cancer Hospital; Peking University International Hospital; Shandong Tumor Hospital
• Treatments: Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Liposomal doxorubicin; Prednisone; Vincristine

Criteria

Inclusion Criteria:

1. Histopathology / cytology diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2016 classification criteria（NK/T cell lymphoma and ALK positive anaplastic large cell lymphoma excluded）including:Peripheral T-cell lymphoma, NOS，Angioimmunoblastic T-cell lymphoma，Anaplastic large-cell lymphoma, ALK negative，Enteropathy-associated T-cell lymphoma，Hepatosplenic T-cell lymphoma，Subcutaneous panniculitis T-cell lymphoma，Mycosis fungoides，Other T-cell lymphoma that investigators consider to be appropriate to be enrolled;

2. Patients have received CHOPE regimen for 2 cycles therapy and achieve PR or SD;

3. Patients should have at least one evaluable foci ( lymph nodes with diameter≥1.5cm, or evaluable skin foci);

4. Age 18-70 years, male or female;

5. ECOG performance status 0-2;

6. Absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L;

7. ALT and serum creatinine <1.5 times of normal maximum;

8. Life expectancy no less than 3 months;

9. Willing to sign the Informed Consent Form.

Exclusion Criteria:

1. NK/T cell lymphoma or ALK positive anaplastic large cell lymphoma;

2. Female patients in lactation or pregnancy, Childbearing female or male patients unwilling to take contraceptive measures;

3. QTc elongation with clinical significance ( male> 450ms, female> 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;

4. Patients have undergone organ transplantation;

5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;

6. Patients with active hemorrhage;

7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;

8. Patients with active infection or continuous fever within 14 days prior to enrollment;

9. Had major organ surgery within 6 weeks prior to enrollment;

10. Impaired liver function ( Total bilirubin > 1.5 times of normal maximum, ALT/AST> 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST> 5 times of normal maximum), impaired renal function (serum creatinine> 1.5 times of normal maximum);

11. Patients with mental disorders or those do not have the ability to consent;

12. Patients with drug abuse, long term alcoholism that may impact the results of the trial;

13. Patients with invasion of central nervous system ;

14. Non-appropriate patients for the trial according to the judgment of the investigators.