Clinical trial NCT04480099: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral T-cell Lymphoma
Keywords: Peripheral T-cell lymphoma
Targeted therapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Complete response rate
timeFrame: At the end of Cycle 6 (each cycle is 21 days)
Secondary outcomes:
measure: Overall response rate
timeFrame: At the end of Cycle 6 (each cycle is 21 days)
measure: Progression free survival
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Overall survival
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Duration of response
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Treatment related mortality
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
timeFrame: 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 outcomes:
measure: Circulating free Deoxyribonucleic Acid (cfDNA) monitoring
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Exploratory biomarker analysis
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
Locations:
city: Beijing
country: China
facility: Department of Hematology, Peking University Third Hospital, Beijing, China
city: Chengdu
country: China
facility: Department of Hematology, West China Hospital, Sichuan University, Chengdu, Sichuan, China
city: Fuzhou
country: China
facility: Department of Hematology, Fujian Institute of Hematology, Fujian Provincial Key Laboratory on Hematology, Union Hospital, Fujian Institute of Hematology, Fuzhou, China
city: Shandong
country: China
facility: Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
city: Wuhan
country: China
facility: Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
city: Wuhan
country: China
facility: Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Study officials:
References: