Targeted Drug Combined With CHOP in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma
- Conditions
- Peripheral T-cell Lymphoma
- Interventions
- Drug: CHOPDrug: CHOP+X
- Registration Number
- NCT04480099
- Lead Sponsor
- Ruijin Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 96
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CHOP CHOP Patients in this arm will receive conventional CHOP regimen for 6 cycles CHOP+X CHOP+X Patients in this arm will receive targeted drug in combination with conventional CHOP regimen for 6 cycles, based on NGS results
- Primary Outcome Measures
Name Time Method Complete response rate At the end of Cycle 6 (each cycle is 21 days) Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
- Secondary Outcome Measures
Name Time Method Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores 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) 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.
Progression free survival Baseline up to data cut-off (up to approximately 4 years) 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 response rate At the end of Cycle 6 (each cycle is 21 days) Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Baseline up to data cut-off (up to approximately 4 years) 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.
Overall survival Baseline up to data cut-off (up to approximately 4 years) 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 Baseline up to data cut-off (up to approximately 4 years) 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 Baseline up to data cut-off (up to approximately 4 years) Percentage of death related with treatment on the basis of investigator assessments
Trial Locations
- Locations (7)
Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China
🇨🇳Shandong, China
Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
🇨🇳Wuhan, China
Department of Hematology, Peking University Third Hospital, Beijing, China
🇨🇳Beijing, China
Department of Hematology, Fujian Institute of Hematology, Fujian Provincial Key Laboratory on Hematology, Union Hospital, Fujian Institute of Hematology, Fuzhou, China
🇨🇳Fuzhou, China
Department of Hematology, West China Hospital, Sichuan University, Chengdu, Sichuan, China
🇨🇳Chengdu, China
Shanghai Ruijin Hospital
🇨🇳Shanghai, China
Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
🇨🇳Wuhan, China