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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05179213
Other study ID # PUMCH-NHL-012
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
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