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

NCT05179213 | Unknown Phase 2

• 1 other identifier: PUMCH-NHL-012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Angioimmunoblastic T-cell Lymphoma

Keywords

Angioimmunoblastic T-cell Lymphoma; Azacytidine; Chidamide

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR was defined as the proportion of patients who achieved CR or PR as their best response

  1year

Secondary Outcomes (4)

• progression-free survival (PFS)

  1 year

• Duration of response (DOR)

  through study completion, an average of 1 year

• overall survival (OS)

  through study completion, an average of 2 year

• Adverse Events

  During the whole treatment

Study Arms (1)

Azacytidine combined with chidamide

EXPERIMENTAL

Patients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days.

Drug: Azacitidine; Drug: Chidamide

Interventions

Azacitidine DRUG

75 mg/m2 subcutaneously on days 1-7

Azacytidine combined with chidamide

Chidamide DRUG

20mg orally per week continuously

Azacytidine combined with chidamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Beijing Longfu Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Immunoblastic Lymphadenopathy

Interventions

Azacitidine; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphadenopathy; Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Wei Zhang, Dr

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Central Study Contacts

Chong Wei, Dr

CONTACT

+86 13521760705; QH5035@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 5, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: May 1, 2024
• Last Updated: January 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)