Targeted Drug Combined With CHOP in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

Shanghai Jiao Tong University

Status and phase: Active, not recruiting; Phase 2

Conditions: Peripheral T-cell Lymphoma

Treatments: Drug: CHOP; Drug: CHOP+X

Study type: Interventional

Funder types: Other

Identifiers

NCT04480099

RJ-PTCL-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

CHOP

Active Comparator group

Description:

Patients in this arm will receive conventional CHOP regimen for 6 cycles

Treatment:

Drug: CHOP

CHOP+X

Experimental group

Description:

Patients in this arm will receive targeted drug in combination with conventional CHOP regimen for 6 cycles, based on NGS results

Treatment:

Drug: CHOP+X