Overview of clinical trials
Learn more about the recent clinical trials and emerging therapeutic options for Waldenström’s macroglobulinemia.
Waldenström’s macroglobulinemia: clinical trials & studies
In this section you can learn more about the recent clinical trials in Waldenström’s macroglobulinemia, and the potential implications of emerging data for novel treatment strategies. The studies selected include those in at least phase II of development where targeted, chemotherapy-free agents are investigated.
Recent studies and evolving treatments
- Emerging treatment options include novel BTK inhibitors and B-cell lymphoma 2 (BCL2) inhibitors, for which a number of clinical trials are currently underway.1,2,3,4,5,6
- Second-generation BTK inhibitors seek to improve bioavailability, increase kinase selectivity and have less off-target effects, with less cardiotoxicity and fewer AEs that may result in stopping treatment.7
- Limiting off-target binding can potentially help reduce adverse events, as inadvertent binding to other kinases, including EGFR, HER4, and TEC, has been linked to side effects such as hypertension, rash, diarrhoea, and bleeding events.7
- Gene expression and transcriptome studies have shown that BCL2 is highly expressed in WM cells, particularly in those patients with activating MYD88 mutations, making it an attractive therapeutic option.6
Selected recent and ongoing trials in patients with Waldenström’s macroglobulinemia
Phase III ibrutinib and zanubrutinib
- ASPEN – a randomized phase III trial comparing the BTK inhibitors, ibrutinib and zanubrutinib1,9
– View study detail
Phase III ibrutinib
- iNNOVATE – a randomized phase III trial comparing ibrutinib (BTK inhibitor) plus rituximab (αCD20 mAb) to rituximab alone2,3
– View study detail
Phase II acalabrutinib
- A single arm, multicenter, phase II study of acalabrutinib (BTK inhibitor) monotherapy4
– View study detail
Phase II tirabrutinib
- A single arm, multicenter, phase II study of tirabrutinib (BTK inhibitor) monotherapy5
– View study detail
Phase II venetoclax
- A single arm, multicenter, phase II study of venetoclax (BCL2 inhibitor) monotherapy10
– View study detail