Azacitidine Combined With Chidamide in the Treatment of Newly Diagnosed PTCL Unfit for Conventional Chemotherapy

• Status: Recruiting
• Trial end date: 2024-06-20
• Target enrollment: 0
• Participant gender: All

Summary

This prospective, open-label, single-arm study will evaluate the efficacy and safety of azacitidine in combination with chidamide in treatment of newly diagnosed peripheral T-cell lymphoma unfit for conventional chemotherapy.

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

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Azacitidine

Criteria

Inclusion Criteria:

• Pathologically confirmed peripheral T-cell lymphoma based on 2016 WHO classification

• Treatment naive

• Age ≥ 18 years

• Unfit for converntional chemotherapy meeting criteria as following but not limited to:

age ≥75, ECOG >2，ADL<100 or CCI>1.

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

• Expected lifetime ≥ 3 months

• Informed consented

Exclusion Criteria:

• Has accepted localized or systemic anti-lymphoma treatment

• Has accepted autologous Stem cell transplantation before

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

• Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease

• Primary CNS lymphoma

• Left EF≤ 50%

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

• Other uncontrollable medical condition that may that may interfere the participation of the study

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

• Patients with mentally disorders or other reasons unable to fully comply with the study protocol

• Pregnant or lactation

• HIV infection

• HBV-DNA and HCV-RNA undectable.