Back to resultsAzacitidine Combined With Chidamide in the Treatment of Newly Diagnosed PTCL Unfit for Conventional Chemotherapy
Primary Purpose
Peripheral T-cell Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Azacitidine
Chidamide
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral T-cell Lymphoma focused on measuring Peripheral T-cell lymphoma, Targeted therapy, Chemo-free therapy
Eligibility Criteria
Inclusion Criteria:
- Pathologically confirmed peripheral T-cell lymphoma based on 2016 WHO classification
- Treatment naive
- Age ≥ 18 years
- Unfit for converntional chemotherapy meeting criteria as following but not limited to: age ≥75, ECOG >2，ADL<100 or CCI>1.
- Must has measurable lesion in CT or PET-CT prior to treatment
- Expected lifetime ≥ 3 months
- Informed consented
Exclusion Criteria:
- Has accepted localized or systemic anti-lymphoma treatment
- Has accepted autologous Stem cell transplantation before
- History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix prior to study treatment
- Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- Primary CNS lymphoma
- Left EF≤ 50%
- Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/ L ;Platelet<75*10^9/L; ALT or AST >2*ULN; Creatinine>1.5*ULN
- Other uncontrollable medical condition that may that may interfere the participation of the study
- Not able to comply to the protocol for mental or other unknown reasons
- Patients with mentally disorders or other reasons unable to fully comply with the study protocol
- Pregnant or lactation
- HIV infection
- HBV-DNA and HCV-RNA undectable.
Sites / Locations
- Shanghai Ruijin HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aza+Chida
Arm Description
Azacitidine ivgtt D1-7 Chindamide 30mg,PO,twice a week Every 21 days for total 6 courses
Outcomes
Primary Outcome Measures
Complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Secondary Outcome Measures
Overall response rate
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Progression free survival
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
Overall survival
Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
Duration of response
Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.
Treatment related mortality
Percentage of death related with treatment on the basis of investigator assessments
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04480125
Brief Title
Azacitidine Combined With Chidamide in the Treatment of Newly Diagnosed PTCL Unfit for Conventional Chemotherapy
Official Title
The Efficacy and Safety of Azacitidine in Combination With Chidamide in the Treatment of Newly Diagnosed Peripheral T-Cell Lymphoma Unfit for Conventional Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2020 (Actual)
Primary Completion Date
June 20, 2022 (Anticipated)
Study Completion Date
June 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This prospective, open-label, single-arm study will evaluate the efficacy and safety of azacitidine in combination with chidamide in treatment of newly diagnosed peripheral T-cell lymphoma unfit for conventional chemotherapy.
Detailed Description
Peripheral T-cell lymphoma (PTCL is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for ~10%. CHOP regimen has been widely used in PTCL patients even with unfavourable prognosis, with 5-year overall survival rate of 38.5%. Elderly patients seldom benefit from conventional CHOP regimen. A study showed that CR rate was only 18.1% in elderly patients (median age of 80 years old, ranging from 56 to 93 years old).
Azacitidine combined with romidepsin has been proved efficient in relasped or refractory PTCL, with CR rate of 55%. This prospective, open-label, single-arm study will evaluate the efficacy and safety of azacitidine in combination with Chidamide in treatment of newly diagnosed peripheral T-cell lymphoma unfit for conventional chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-cell Lymphoma
Keywords
Peripheral T-cell lymphoma, Targeted therapy, Chemo-free therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aza+Chida
Arm Type
Experimental
Arm Description
Azacitidine ivgtt D1-7 Chindamide 30mg,PO,twice a week Every 21 days for total 6 courses
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
100mg D1-7
Intervention Type
Drug
Intervention Name(s)
Chidamide
Intervention Description
30mg BIW PO
Primary Outcome Measure Information:
Title
Complete response rate
Description
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Time Frame
At the end of Cycle 6 (each cycle is 21 days)
Secondary Outcome Measure Information:
Title
Overall response rate
Description
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Time Frame
At the end of Cycle 6 (each cycle is 21 days)
Title
Progression free survival
Description
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Overall survival
Description
Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Duration of response
Description
Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Treatment related mortality
Description
Percentage of death related with treatment on the basis of investigator assessments
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE
Description
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Description
The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.
Time Frame
: Baseline (pre-dose [Hour 0] on Cycle1 Day1), Cycle3 Day 1, end of treatment (up to Month 6), every 3 months 1st year, every 6 months 2nd year, and 12 months thereafter up to data cut-off, up to approximately 4 years (cycle length = 21 days)
Other Pre-specified Outcome Measures:
Title
Circulating free Deoxyribonucleic Acid (cfDNA) monitoring
Description
CfDNA in peripheral blood assessed by local lab
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Exploratory biomarker analysis
Description
Exploratory biomarker to predict treatment response and survival
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathologically confirmed peripheral T-cell lymphoma based on 2016 WHO classification
Treatment naive
Age ≥ 18 years
Unfit for converntional chemotherapy meeting criteria as following but not limited to: age ≥75, ECOG >2，ADL<100 or CCI>1.
Must has measurable lesion in CT or PET-CT prior to treatment
Expected lifetime ≥ 3 months
Informed consented
Exclusion Criteria:
Has accepted localized or systemic anti-lymphoma treatment
Has accepted autologous Stem cell transplantation before
History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix prior to study treatment
Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
Primary CNS lymphoma
Left EF≤ 50%
Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/ L ;Platelet<75*10^9/L; ALT or AST >2*ULN; Creatinine>1.5*ULN
Other uncontrollable medical condition that may that may interfere the participation of the study
Not able to comply to the protocol for mental or other unknown reasons
Patients with mentally disorders or other reasons unable to fully comply with the study protocol
Pregnant or lactation
HIV infection
HBV-DNA and HCV-RNA undectable.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Zhao, PhD，MD
Phone
+862164370045
Email
zwl_trial@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pengpeng Xu, PhD，MD
Phone
+862164370045
Email
pengpeng_xu@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weili Zhao
Organizational Affiliation
Ruijin Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, M.D. and Ph.D
Phone
021-64370045
Email
zwl_trial@163.com
12. IPD Sharing Statement
Learn more about this trial
Azacitidine Combined With Chidamide in the Treatment of Newly Diagnosed PTCL Unfit for Conventional Chemotherapy
We'll reach out to this number within 24 hrs