Study Evaluating the Safety and Efficacy of C-CHOP in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-arm, open-label phase 2study of Chidamide in combination with CHOP in the treatment of subjects with untreated angioimmunoblastic T cell lymphoma.

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

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Vincristine

Criteria

Inclusion Criteria:

1. Pathologically confirmed angioimmunoblastic T cell lymphoma

2. Treatment naive

3. Age > 18 years

4. Must has measurable lesion in CT or PET-CT prior to treatment

5. ECOG 0,1,2

6. Informed consented

Exclusion Criteria:

1. Has accepted Chemotherapy before

2. Has accepted autologous Stem cell transplantation before

3. History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3 years prior to study treatment

4. Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease

5. Primary CNS lymphoma

6. LVEF≤50%

7. Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/L ;Platelet<75*10^9/L; ALT or AST >2*ULN; AKP or bilirubin >1.5*ULN ;Creatinine>1.5*ULN

8. Other uncontrollable medical condition that may that may interfere the participation of the study

9. Not able to comply to the protocol for mental or other unknown reasons

10. Pregnant or lactation

11. HIV infection

12. If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.