Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

Conditions

• Waldenström's Macroglobulinemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ibrutinib — DRUG
  Participants will receive 420 mg of Ibrutinib orally.
• Placebo — DRUG
  Participants will receive placebo capsules orally.
• Rituximab — DRUG
  Participants will receive rituximab 375 mg/m\^2 IV.

Study Details

The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in participants with Waldenström's macroglobulinemia (WM).

Key Dates

Start date

Jul 7, 2014

Status verified

Dec 2020

Primary completion

Nov 7, 2019

Completion

Nov 7, 2019

Study Design

Enrollment

181 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Randomized Study (Ibrutinib + Rituximab)
  Ibrutinib: 420 mg (3 capsules x 140 mg) orally administered daily beginning from Day 1. Rituximab: 375 mg/m\^2 intravenous (IV) per package insert weekly for four consecutive weeks, followed by a second four-weekly rituximab course after a three-month interval.
• Experimental: Randomized Study (Placebo + Rituximab)
  Placebo: 3 capsules of placebo orally administered daily beginning from Day 1. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks, followed by a second four-weekly rituximab course after a three-month interval.
• Experimental: Open-Label Substudy (Ibrutinib)
  Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1.

Primary Outcome Measure

Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 54 [ Time Frame: Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr]) ]

Locations (10)

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