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

Angioimmunoblastic T-cell Lymphoma Clinical Trial

Official title:

Azacytidine Combined With Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma: a Multicenter Single Arm Phase II Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05179213
• Other study ID #: PUMCH-NHL-012
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: December 2021
• Source: Peking Union Medical College Hospital
• Contact: Chong Wei, Dr
• Phone: +86 13521760705
• Email: QH5035[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Angioimmunoblastic T-cell Lymphoma
• Lymphoma
• Lymphoma, T-Cell

Intervention

Drug:
• Azacitidine
75 mg/m2 subcutaneously on days 1-7
• Chidamide
20mg orally per week continuously

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Longfu Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	ORR was defined as the proportion of patients who achieved CR or PR as their best response	1year
Secondary	progression-free survival (PFS)	PFS was defined as time from diagnosis to the date of disease progression or death from any cause or the last follow-up.	1 year
Secondary	Duration of response (DOR)	DOR was defined as the time from the first occurrence of CR or PR to the first diagnosis of PD or relapse.	through study completion, an average of 1 year
Secondary	overall survival (OS)	OS was defined as time from diagnosis to death from any cause or the last follow-up.	through study completion, an average of 2 year
Secondary	Adverse Events	Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	During the whole treatment