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Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia

NCT03679624 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-10-23

Study results available
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Summary

This study evaluates the safety and efficacy of daratumumab in combination with ibrutinib in patients with Waldenstrӧm's macroglobulinemia (WM). The study will evaluate this combination in two cohorts. Cohort A will comprise of ibrutinib naïve WM patients. Patients in this cohort may be treatment naïve or relapsed but who remain ibrutinib naïve. Cohort B will comprise of patients who are currently receiving ibrutinib but whose response to treatment has plateaued. In this cohort, daratumumab will be added on to ibrutinib in an attempt to deepen response.

Conditions

  • Waldenstrom Macroglobulinemia
  • Waldenstrom's Disease
  • Waldenström; Hypergammaglobulinemia
  • Waldenstrom's Macroglobulinemia Recurrent
  • Waldenstrom's Macroglobulinemia of Lymph Nodes
  • Waldenstrom's Macroglobulinaemia, Without Mention of Remission
  • Waldenstrom's Macroglobulinemia Refractory

Interventions

DRUG

Ibrutinib

Ibrutinib, 420mg orally, once daily

DRUG

Daratumumab

Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • Mayo Clinic

    collaborator OTHER

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • John N. Allan, M.D. · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2020-09-15
Completion
2020-10-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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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 NCT03679624 on ClinicalTrials.gov