Back to resultsAzacytidine Plus Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma
Primary Purpose
Angioimmunoblastic T-cell Lymphoma
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Azacitidine
Chidamide
Sponsored by
About this trial
This is an interventional treatment trial for Angioimmunoblastic T-cell Lymphoma focused on measuring Angioimmunoblastic T-cell Lymphoma, Azacytidine, Chidamide
Eligibility Criteria
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;
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Azacytidine combined with chidamide
Arm Description
Patients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days.
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR)
ORR was defined as the proportion of patients who achieved CR or PR as their best response
Secondary Outcome Measures
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.
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.
overall survival (OS)
OS was defined as time from diagnosis to death from any cause or the last follow-up.
Adverse Events
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Full Information
NCT ID
NCT05179213
First Posted
December 8, 2021
Last Updated
December 20, 2021
Sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Longfu Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05179213
Brief Title
Azacytidine Plus Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma
Official Title
Azacytidine Combined With Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma: a Multicenter Single Arm Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Longfu Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angioimmunoblastic T-cell Lymphoma
Keywords
Angioimmunoblastic T-cell Lymphoma, Azacytidine, Chidamide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Azacytidine combined with chidamide
Arm Type
Experimental
Arm Description
Patients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days.
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
75 mg/m2 subcutaneously on days 1-7
Intervention Type
Drug
Intervention Name(s)
Chidamide
Intervention Description
20mg orally per week continuously
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR was defined as the proportion of patients who achieved CR or PR as their best response
Time Frame
1year
Secondary Outcome Measure Information:
Title
progression-free survival (PFS)
Description
PFS was defined as time from diagnosis to the date of disease progression or death from any cause or the last follow-up.
Time Frame
1 year
Title
Duration of response (DOR)
Description
DOR was defined as the time from the first occurrence of CR or PR to the first diagnosis of PD or relapse.
Time Frame
through study completion, an average of 1 year
Title
overall survival (OS)
Description
OS was defined as time from diagnosis to death from any cause or the last follow-up.
Time Frame
through study completion, an average of 2 year
Title
Adverse Events
Description
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame
During the whole treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chong Wei, Dr
Phone
+86 13521760705
Email
QH5035@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, Dr
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Azacytidine Plus Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma
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