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

NCT04480099 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-06-13

No results posted yet for this study

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.

Conditions

  • Peripheral T-cell Lymphoma

Interventions

DRUG

CHOP

Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses

DRUG

CHOP+X

X: X(i.e. targeted drug) will decided by NGS results as following. Decitabine 10mg/m2 ivgtt D-5 to-1 if with TP53 gene muation. Azacitadine 100mg/day ivgtt D-7 to -1 if with TET2/KMT2D gene mutation. Chidamide 20mg/day po D1,4,8,11 if with CREBBP/EP300 gene mutation. Lenalidomide 25mg/day po D1-10 if without gene mutation above. X will be added from the second cycle CHOP:Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-29
Primary Completion
2023-04-20
Completion
2024-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04480099 on ClinicalTrials.gov