IBER Salvage Treatment Followed by Ibrutinib Maintenance for Relapsed or Refractory PCNSL

Sponsor
Deok-Hwan Yang
Study ID
NCT04066920
Phase
PHASE2
Status
Unknown

Conditions

  • Primary Central Nervous System Lymphoma

Eligibility Criteria

Sex
ALL
Age
20 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a multicenter, single-arm, prospective phase II study to evaluate the efficacy and safety of a novel combination regimen for relapsed/refractory PCNSL. Specifically, ibrutinib will be administered in combination with ifosfamide, etoposide and rituximab (IBER) as a salvage chemotherapy, which is followed by maintenance ibrutinib monotherapy of fixed duration.

Key Dates

Start date
Oct 1, 2019
Status verified
Aug 2019
Primary completion
Sep 30, 2021
Completion
Sep 30, 2023

Study Design

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

Arms

  • Experimental: IBER treatment arm
    This is the only arm in a single-arm phase II study.

Primary Outcome Measure

Overall response rate [ Time Frame: From date of starting the study treatment until the date of finishing the study treatment for any reason, assessed up to 10 months ]

Central Contacts

Related Studies