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.

Study Overview

• Status: Not yet recruiting
• Conditions: Angioimmunoblastic T-cell Lymphoma
• Intervention / Treatment: Drug: Azacitidine; Drug: Chidamide

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chong Wei, Dr; Phone Number: +86 13521760705; Email: QH5035@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Azacytidine combined with chidamide; Patients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days.	Drug: Azacitidine; 75 mg/m2 subcutaneously on days 1-7; Drug: Chidamide; 20mg orally per week continuously

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Adverse Events	Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	During the whole treatment

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Beijing Longfu Hospital
• Investigators: Study Director: Wei Zhang, Dr, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Chidamide; Azacytidine; Angioimmunoblastic T-cell Lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphadenopathy; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Immunoblastic Lymphadenopathy; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Azacitidine
• Other Study ID Numbers: PUMCH-NHL-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No