Chidamide in Patients With Recurrent and Refractory Diffuse Large b

Sponsor
Second Affiliated Hospital of Soochow University
Study ID
NCT05690191
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chidamide — DRUG
    Chidamide tablets: 20mg orally, twice a week (at least 3 days between doses
  • Lenalidomide — DRUG
    Lenalidomide capsule: 25mg orally, once before going to bed every night, from day 1 to day 21 of each cycle
  • Rituximab — DRUG
    Rituximab injection: 375mg/m2 intravenously, once every 4 weeks (Q4w), on the first day of each cycle

Study Details

A Multicenter, Prospective, Observational Clinical Protocol for Chidamide in Combination With Rituximab and Lenalidomide (cR2) in Real-world Practice in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Key Dates

First listed
Jan 19, 2023
Start date
Jun 1, 2021
Status verified
Jan 2023
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
169 participants (estimated)

Arms

  • Arm: Chidamide in combination with rituximab and lenalidomide
    Chidamide tablets: 20mg orally, twice a week (at least 3 days between doses); Rituximab injection: 375mg/m2 intravenously, once every 4 weeks (Q4w), on the first day of each cycle; Lenalidomide capsule: 25mg orally, once before going to bed every night, from day 1 to day 21 of each cycle

Primary Outcome Measure

Objective response rate [ Time Frame: 30 months ]

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