Chidamide Combined With Cyclophosphamide, Prednisone, Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma

• Status: Unknown status
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate efficacy and safety of Chidamide Combined With Cyclophosphamide,Prednisone,Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma :a Phase II,Single-arm,Open-label, Muti-center Study

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

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Treatments: Cyclophosphamide; Prednisone; Thalidomide

Criteria

Inclusion Criteria:

1. Histologically confirmed Peripheral T Cell Lymphoma,exclude NK/T cell lymphoma

2. Relapse or refractory to at least one prior therapy(chemotherapy or stem cell transplantation)

3. can not

4. age between 18 and 75, both gender

5. ECOG PS 0-1

6. Peripheral ANC >1.5*109/L; platelet >70*109/L; Hb≥ 90g/L

7. Anticipated survival ≥ 3 months

8. No chemotherapy ,radiotherapy and stem cell transplantation within 4 weeks before inclusion

9. Sign in informed consent form, adherence to the study visit schedule and other protocol requirements

Exclusion Criteria:

1. Pregnant women or women in suckling period or with Potentia Generand but not willing to take contraceptives

2. New York Heart Association class III or IV cardiac failure; or history of following disease in past 6 months: acute coronary syndrome, acute heart failure, severe ventricular arrhythmia

3. Poor hepatic function, defined as total bilirubin more than 1.5 fold of upper normal level, ALT, AST more than 2 fold of upper normal level or more than 5fold of upper normal level with hepatic involvement;Poor renal function, defined as serum creatinine more than 1.5 fold of upper normal level

4. CNS or meningeal involvement

5. intervention on myelosuppression within7 days before inclusion

6. patients with active bleeding

7. Major surgery within three weeks before inclusion

8. Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)> 1×105 copies/ml;

9. Any psychological conditions which may disturb consent.

10. In any conditions which investigator considered ineligible

11. Known sensitivity or allergy to investigational Product.