NCT03506373

Ibrutinib and Ixazomib Citrate in Treating Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia

Phase II Study of Ibrutinib in Combination With Ixazomib in Patients With Waldenström Macroglobulinemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects of ibrutinib citrate when given with ixazomib, and determines how well they work in treating patients with Waldenstrom macroglobulinemia that is newly diagnosed, has come back (recurrent) or does not respond to treatment (refractory). Enzyme inhibitors, such as ibrutinib and ixazomib citrate, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVE: I. To determine the efficacy (as assessed by complete response \[CR\] rate) of the combination of ixazomib citrate (ixazomib) and ibrutinib in Waldenstrom macroglobulinemia (WM) patients. SECONDARY OBJECTIVES: I. To assess the overall response rate (ORR=partial response \[PR\] or better) in WM patients treated with ixazomib and ibrutinib. II. To assess the time to progression (TTP) in WM patients treated with ixazomib and ibrutinib. III. To further characterize the safety and toxicity of the combination of ibrutinib and ixazomib. IV. To assess the overall survival (OS) in WM patients treated with ixazomib and ibrutinib. CORRELATIVE RESEARCH OBJECTIVES: I. To determine the role of members of the BTK signalosome in achievement or lack thereof of response to ibrutinib and ixazomib. II. To explore biologic effects of ibrutinib and ixazomib on microenvironment in WM and correlate with response to treatment. OUTLINE: Patients receive ixazomib citrate orally (PO) on days 1, 8, and 15 and ibrutinib PO daily on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 2 years.

Conditions

• Recurrent Waldenstrom Macroglobulinemia
• Refractory Waldenstrom Macroglobulinemia
• Waldenstrom Macroglobulinemia

Interventions

Type	Name	Description
DRUG	Ibrutinib	Given PO
DRUG	Ixazomib Citrate	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacodynamic Study	Correlative studies
OTHER	Pharmacokinetic Study	Correlative studies

Timeline

• Start date: 2018-08-14
• Primary completion: 2023-02-06
• Completion: 2026-02-03
• First posted: 2018-04-24
• Last updated: 2026-03-05
• Results posted: 2025-09-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study