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Efficacy of First Line B-RI for Treatment Naive Waldenström's Macroglobulinemia

NCT03620903 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-12-05

No results posted yet for this study

Summary

In Waldenström macroglobulinemia (WM) conventional chemotherapy induces only low complete remission (CR) rates and responses of short duration compared to other indolent lymphomas. Thus innovative approaches are needed which combine excellent activity and tolerability in patients with WM, who are mostly of advanced age. The immunochemotherapy DRC (dexamethasone, rituximab, cyclophosphamide) was shown to be highly effective in patients with WM without inducing major hematological toxicities. On the other hand the proteasome inhibitor bortezomib showed substantial activity as a single agent in WM with only very few side effects when given in a weekly schedule. Recent data confirmed high activity with low toxicity for ibrutinib in relapsed WM patients as single agent therapy. Based on these observations it is the aim of this study to investigate the efficacy and toxicity of the chemotherapy-free combination bortezomib, rituximab, ibrutinib (B-RI) in treatment naïve WM patient.

Conditions

Interventions

DRUG

Ibrutinib / Bortezomib / Rituximab

Induction (Rituximab / Bortezomib / Ibrutinib), Maintenance I (Ibrutinib / Rituximab), Maintenance II (Ibrutinib)

Sponsors & Collaborators

  • University of Ulm

    collaborator OTHER

  • ClinAssess GmbH

    collaborator INDUSTRY

  • Zentrum für Klinische Studien Ulm

    collaborator OTHER

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Johnson & Johnson

    collaborator INDUSTRY

  • Christian Buske

    lead OTHER

Principal Investigators

  • Christian Buske, MD · University of Ulm

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-11
Primary Completion
2022-11-14
Completion
2027-02-28

Countries

  • Germany
  • Greece

Study Locations

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Entities

Diseases
Companies

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 NCT03620903 on ClinicalTrials.gov