Back to resultsTargeted Drug Combined With CHOP in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma
Primary Purpose
Peripheral T-cell Lymphoma
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CHOP
CHOP+X
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
Eligibility Criteria
Inclusion Criteria:
- Pathologically confirmed peripheral T-cell lymphoma based on 2016 WHO classification with enough tumor sample for NGS
- Treatment naive
- Age ≥ 18 years
- Must has measurable lesion in CT or PET-CT prior to treatment
- ECOG 0,1,2
- Informed consented
Exclusion Criteria:
- ALCL,ALK positive, NK/T-cell leukemia, adult T-cell lymphoma/leukemia, T-LGL
- 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<50*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 or HCV-RNA positive
Sites / Locations
- Department of Hematology, Peking University Third Hospital, Beijing, China
- Department of Hematology, West China Hospital, Sichuan University, Chengdu, Sichuan, China
- Department of Hematology, Fujian Institute of Hematology, Fujian Provincial Key Laboratory on Hematology, Union Hospital, Fujian Institute of Hematology, Fuzhou, China
- Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China
- Shanghai Ruijin Hospital
- Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
- Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CHOP
CHOP+X
Arm Description
Patients in this arm will receive conventional CHOP regimen for 6 cycles
Patients in this arm will receive targeted drug in combination with conventional CHOP regimen for 6 cycles, based on NGS results
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
NCT04480099
Brief Title
Targeted Drug Combined With CHOP in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma
Official Title
The Efficacy and Safety of Targeted Drug in Combination With Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in the Treatment of Newly Diagnosed Peripheral T-Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 29, 2020 (Actual)
Primary Completion Date
April 20, 2023 (Actual)
Study Completion Date
April 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，multi-center，open-label, controlled study will evaluate the efficacy and safety of targeted drug in combination with CHOP in treatment of newly diagnosed peripheral T-cell lymphoma.
Detailed Description
Peripheral T-cell lymphoma (PTCL）is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for ~10%. Patients with PTCL still have poor treatment response and prognosis under conventional CHOP regimen. There is no standard of care for those patients. Targeted drugs are warranted in this group of patients to improve survival. This prospective，multi-center，open-label, controlled study will evaluate the efficacy and safety of targeted drug in combination with CHOP in treatment of newly diagnosed peripheral T-cell lymphoma.
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHOP
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive conventional CHOP regimen for 6 cycles
Arm Title
CHOP+X
Arm Type
Experimental
Arm Description
Patients in this arm will receive targeted drug in combination with conventional CHOP regimen for 6 cycles, based on NGS results
Intervention Type
Drug
Intervention Name(s)
CHOP
Intervention Description
Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses
Intervention Type
Drug
Intervention Name(s)
CHOP+X
Intervention Description
X: X(i.e. targeted drug) will decided by NGS results as following. Decitabine 10mg/m2 ivgtt D-5 to-1 if with TP53 gene muation. Azacitadine 100mg/day ivgtt D-7 to -1 if with TET2/KMT2D gene mutation. Chidamide 20mg/day po D1,4,8,11 if with CREBBP/EP300 gene mutation. Lenalidomide 25mg/day po D1-10 if without gene mutation above. X will be added from the second cycle CHOP:Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses
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 with enough tumor sample for NGS
Treatment naive
Age ≥ 18 years
Must has measurable lesion in CT or PET-CT prior to treatment
ECOG 0,1,2
Informed consented
Exclusion Criteria:
ALCL,ALK positive, NK/T-cell leukemia, adult T-cell lymphoma/leukemia, T-LGL
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<50*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 or HCV-RNA positive
Facility Information:
Facility Name
Department of Hematology, Peking University Third Hospital, Beijing, China
City
Beijing
Country
China
Facility Name
Department of Hematology, West China Hospital, Sichuan University, Chengdu, Sichuan, China
City
Chengdu
Country
China
Facility Name
Department of Hematology, Fujian Institute of Hematology, Fujian Provincial Key Laboratory on Hematology, Union Hospital, Fujian Institute of Hematology, Fuzhou, China
City
Fuzhou
Country
China
Facility Name
Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China
City
Shandong
Country
China
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
Country
China
Facility Name
Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
City
Wuhan
Country
China
Facility Name
Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
City
Wuhan
Country
China
12. IPD Sharing Statement
Learn more about this trial
Targeted Drug Combined With CHOP in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma
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