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

  • STATUS
    Recruiting
  • participants needed
    106
  • sponsor
    Ruijin Hospital
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Updated on 5 August 2020
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measurable disease
lymphoma
pet/ct scan
peripheral t-cell lymphoma
t-cell lymphoma

Summary

This prospectivemulti-centeropen-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.

Description

Peripheral T-cell lymphoma (PTCLis 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 prospectivemulti-centeropen-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.

Details
Condition Peripheral T-Cell Lymphoma, T-Cell Lymphoma, T-Cell Lymphoma
Age 18years - 100years
Treatment CHOP for 6 cycles, CHOP+X for 6 cycles
Clinical Study IdentifierNCT04480099
SponsorRuijin Hospital
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
Clear my responses
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