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

Phase 2

• Conditions: Angioimmunoblastic T-cell Lymphoma
• Interventions: Drug: Azacitidine; Drug: Chidamide

• Registration Number: NCT05179213
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-20
• Last Update Submitted: 2021-12-20
• Study Start: 2022-01-01
• Study First Posted: 2022-01-05
• Last Update Posted: 2022-01-05
• Primary Completion: 2024-01-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Azacytidine combined with chidamide	Azacitidine	Patients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days.
Azacytidine combined with chidamide	Chidamide	Patients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	1year	ORR was defined as the proportion of patients who achieved CR or PR as their best response

Secondary Outcome Measures

Name	Time	Method
progression-free survival (PFS)	1 year	PFS was defined as time from diagnosis to the date of disease progression or death from any cause or the last follow-up.
Duration of response (DOR)	through study completion, an average of 1 year	DOR was defined as the time from the first occurrence of CR or PR to the first diagnosis of PD or relapse.
overall survival (OS)	through study completion, an average of 2 year	OS was defined as time from diagnosis to death from any cause or the last follow-up.
Adverse Events	During the whole treatment	Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China