Clinical Trials Logo

Clinical Trial Summary

This is a phase II study in relapsed/refractory WM patients treated with perifosine. It is designed to assess the proportion of overall confirmed responses (CR + PR + MR) using a two-stage phase II study design to permit early stopping of the trial if there is strong evidence that the study regimen is inactive. In addition, it will assess toxicity of this drug in patients with WM. Patients will receive perifosine 150 mg qhs daily. Patients will be assessed by serum immunoelectrophoresis and IgM level at least every 4 weeks.


Clinical Trial Description

This is a phase II study in relapsed/refractory WM patients treated with perifosine. It is designed to assess the proportion of overall confirmed responses (CR + PR + MR) using a two-stage phase II study design to permit early stopping of the trial if there is strong evidence that the study regimen is inactive. In addition, it will assess toxicity of this drug in patients with WM. Patients will receive perifosine 150 mg qhs daily. Patients will be assessed by serum immunoelectrophoresis and IgM level at least every 4 weeks.

Patients will take three 50 mg tablets of perifosine qhs daily (for 28 days cycles) with food. Patients may need anti-emetics and/or anti-diarrheas. All patients should continue therapy unless disease progression is documented on two occasions at least 1 week apart. Patients with progressive disease or who refuse further therapy will be discontinued from the protocol. Dose modifications for toxicity will be performed.

Standard criteria for evaluation of response in WM recommended by the Second International WM Workshop will be used in this study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00398710
Study type Interventional
Source AEterna Zentaris
Contact
Status Completed
Phase Phase 2
Start date October 2006
Completion date October 2011

See also
  Status Clinical Trial Phase
Completed NCT01788020 - Efficacy of First Line DRC +/- Bortezomib for Patients With Waldenström's Macroglobulinemia Phase 3
Recruiting NCT03697356 - R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia Phase 2
Completed NCT02165397 - Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia Phase 3
Completed NCT03053440 - A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM) Phase 3
Recruiting NCT05979948 - A Phase 2 Clinical Trial to Evaluate Zanubrutinib Combined With BR (Bendamustine/Rituximab) Regimen in Subjects With Newly-diagnosed Waldenström's Macroglobulinemia Phase 2
Recruiting NCT05326308 - Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma