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

NCT04066920 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-08-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

IBER salvage chemotherapy followed by ibrutinib maintenance therapy

Induction therapy with IBER (up to 6 cycles) \[ Ibrutinib 560 mg/d on D1-21 + Rituximab 375 mg/m2 on D1 (on D1/8/15 in C1) + Ifosfamide 3.75 g/m2 on D2 + Etoposide 100 mg/m2 on D2-4 \], followed by ibrutinib 560 mg/d maintenance therapy for up to 6 months

Sponsors & Collaborators

  • Deok-Hwan Yang

    lead OTHER

Principal Investigators

  • Deok-Hwan Yang · Chonnam National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2021-09-30
Completion
2023-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT04066920 on ClinicalTrials.gov