Azacytidine Plus Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with chidamide in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma.

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

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: Beijing Longfu Hospital
• Treatments: Azacitidine

Criteria

Inclusion Criteria:

• Pathologically confirmed angioimmunoblastic T-cell lymphoma according World Health Organization (WHO) classification;

• Age≥18years;

• ECOG≤2;

• Patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment;

• Adequate bone marrow hematopoietic function: ANC>1.5 × 109/L，HGB>90g/L，PLT>80 × 109/L;

• Adequate organ function: ALT≤3 times ULN, TBil≤1.5 times ULN, SCr≥50ml/min/m2, cardiac function grade 0-2 (NYHA);

Exclusion Criteria:

• Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;

• Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy;

• Pregnant or lactating women;