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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown

Phase 2

Conditions

Angioimmunoblastic T-cell Lymphoma

Treatments

Drug: Chidamide

Drug: Azacitidine

Study type

Interventional

Funder types

Other

Identifiers

NCT05179213

PUMCH-NHL-012

Details and patient eligibility

About

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.

Full description

Azacytidine was given subcutaneously at a dose of 75 mg/m2 on days 1-7. Chidamide was an oral tablet which was administered 20mg twice weekly. This regimen was repeated every 28 days. Treatment was given until disease progression, unacceptable toxicity, or patient/investigator discretion.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;