Biomarker Guided Treatment in DLBCL

Sponsor
Ruijin Hospital
Study ID
NCT04025593
Phase
PHASE2
Status
Unknown

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    750mg/m2 day 1
  • Rituximab — DRUG
    375mg/m2 day 0
  • Doxorubicin — DRUG
    50mg/m2 day 1
  • Vincristine — DRUG
    1.4mg/m2, max 2mg day 1
  • Prednisone — DRUG
    60mg/m2, max 100mg day 1-5
  • Ibrutinib — DRUG
    420mg/day qd
  • Lenalidomide — DRUG
    25mg day1-10
  • chidamide — DRUG
    20mg day 1,4,8,11
  • decitabine — DRUG
    decitabine 10mg/m2 day-5 to day-1

Study Details

This study is to investigate the strategy of biomarker guided treatment in diffuse large B cell lymphoma

Key Dates

Start date
Jul 17, 2019
Status verified
Nov 2020
Primary completion
Jul 1, 2021
Completion
Jun 1, 2023

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: RCHOP
  • Experimental: RCHOPX

Primary Outcome Measure

complete response rate [ Time Frame: 21 days after 6 cycles of treatment (each cycle is 21 days) ]

Central Contacts

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