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
Overview
- Phase
- Phase 2
- Intervention
- CHOP
- Conditions
- Peripheral T-cell Lymphoma
- Sponsor
- Ruijin Hospital
- Enrollment
- 96
- Locations
- 7
- Primary Endpoint
- Complete response rate
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Zhao Weili
First Deputy Director，Hematology Department
Ruijin Hospital
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
Arms & Interventions
CHOP
Patients in this arm will receive conventional CHOP regimen for 6 cycles
Intervention: CHOP
CHOP+X
Patients in this arm will receive targeted drug in combination with conventional CHOP regimen for 6 cycles, based on NGS results
Intervention: CHOP+X
Outcomes
Primary Outcomes
Complete response rate
Time Frame: 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 Outcomes
- 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))
- Progression free survival(Baseline up to data cut-off (up to approximately 4 years))
- Overall response rate(At the end of Cycle 6 (each cycle is 21 days))
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE(Baseline up to data cut-off (up to approximately 4 years))
- Overall survival(Baseline up to data cut-off (up to approximately 4 years))
- Duration of response(Baseline up to data cut-off (up to approximately 4 years))
- Treatment related mortality(Baseline up to data cut-off (up to approximately 4 years))