Study Evaluating the Safety and Efficacy of iR2 in Untreated and Unfit Elderly Patients With DLBCL

Sponsor
Ruijin Hospital
Study ID
NCT03949062
Phase
PHASE2
Status
Unknown

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    Ibrutinib 560mg per day administered orally on Day 1-21 of each 21-day cycle for 6 cycles
  • Lenalidomide — DRUG
    Lenalidomide 25mg per day administered orally on Day 1-10 of each 21-day cycle for 6 cycles
  • Rituximab — DRUG
    Rituximab 375mg/m2 per day administered intraveneously on Day 1 of each 21-day cycle for 6 cycles

Study Details

This is a single-arm, open-label phase 2 study of iR2 in the treatment of unfit and elderly patients with untreated diffuse large B-cell lymphoma。

Key Dates

Start date
Mar 13, 2019
Status verified
Feb 2021
Primary completion
Mar 31, 2021
Completion
May 31, 2022

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: iR2
    Participants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).

Primary Outcome Measure

Complete response rate [ Time Frame: At the end of Cycle 6 (each cycle is 21 days) ]

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