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

NCT04066920 | Unknown Phase 2

• 1 other identifier: IBER
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Primary Central Nervous System Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  The percentage of patients with a complete response (CR) or a partial response (PR)

  From date of starting the study treatment until the date of finishing the study treatment for any reason, assessed up to 10 months

Secondary Outcomes (1)

• Safety and tolerability of the study treatment

  From the first day of the first cycle of IBER induction chemotherapy to 30 days after the last dose of study drug, assessed up to 12 months

Study Arms (1)

IBER treatment arm

EXPERIMENTAL

This is the only arm in a single-arm phase II study.

Drug: IBER salvage chemotherapy followed by ibrutinib maintenance therapy

Interventions

IBER salvage chemotherapy followed by ibrutinib maintenance therapy DRUG

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

IBER treatment arm

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed PCNSL of CD20+ diffuse large B cell lymphoma (DLBCL)
• PCNSL relapsed or refractory after frontline methotrexate-based chemotherapy (with or without radiation therapy)
• At least one measurable lesion, which is defined as longest diameter of lesion \> 0.5 cm, by contrast-enhanced MRI
• ECOG performance status 0-2
• Normal function of major organs

You may not qualify if:

• PCNSL other than DLBCL
• Primary ocular lymphoma
• PCNSL accompanied by systemic involvement
• Active infection with hepatitis B or C virus
• Known history of human immunodeficiency virus (HIV) infection
• Therapy with myelosuppressive chemotherapy or biologic therapy \< 21 days prior to registration

Sponsors & Collaborators

• Deok-Hwan Yang: lead

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 519-809, South Korea

Location

Related Publications (16)

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Study Officials

• Deok-Hwan Yang

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deok-Hwan Yang, M.D., Ph.D.

CONTACT

+82-61-379-7636; drydh1685@hotmail.com

Yoon Seok Choi, M.D., Ph.D.

CONTACT

+82-42-280-7107; wyfran@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 26, 2019
• Study Start: October 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2023
• Last Updated: August 26, 2019

Record last verified: 2019-08

Locations

KR (1)