Azacytidine Plus Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma
Azacytidine Combined With Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma: a Multicenter Single Arm Phase II Study
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.
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
Overall Response Rate (ORR)
progression-free survival (PFS)
Angioimmunoblastic T-cell Lymphoma
Study Arms / Comparison Groups
Azacytidine combined with chidamide
Description: Patients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
January 1, 2022
May 1, 2024
Primary Completion Date
January 1, 2024
- Pathologically confirmed angioimmunoblastic T-cell lymphoma according World Health
Organization (WHO) classification;
- 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);
- Active or uncontrolled infections requiring systemic treatment within 14 days before
- Any instability of systemic disease, including but not limited to severe cardiac,
liver, kidney, or metabolic disease need therapy;
- Pregnant or lactating women;