Waldenström's Macroglobulinemia Clinical Trial
Official title:
A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia
Verified date | November 2011 |
Source | AEterna Zentaris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | October 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age >= 18 years. - Must have received prior therapy for their WM and have relapsed or refractory WM. Any number of prior therapies is acceptable. - Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of > 2 times the upper limit of each institution's normal value is required and over 10% of lymphoplasmacytic cells in the bone marrow. - ECOG Performance Status (PS) 0, 1, or 2. - The following laboratory values obtained 14 days prior to registration - ANC >= 1 x109/L - PLT >= 75 x109/L - Total bilirubin = 2.0 mg/dL (If total is elevated check direct and if normal patient is eligible.) - AST <= 3 x upper limit of normal (ULN) - Creatinine <= 2 x ULN - Ability to provide informed consent. - Life expectancy >= 12 weeks. Exclusion Criteria: - Uncontrolled infection. - Other active malignancies. - CNS involvement. - Cytotoxic chemotherapy = 3 weeks, or biologic therapy = 2 weeks, or corticosteroids = 2 weeks, prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than WM such as auto-immune diseases. Plasmapheresis is not considered as an active therapy and can be used at the physician's discretion. - Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational. - Any of the following: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device (IUD), or abstinence, etc.) - Known to be HIV positive. - Radiation therapy = 2 weeks prior to registration. |
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
AEterna Zentaris | Dana-Farber Cancer Institute |
United States,
Ghobrial IM, Roccaro A, Hong F, Weller E, Rubin N, Leduc R, Rourke M, Chuma S, Sacco A, Jia X, Azab F, Azab AK, Rodig S, Warren D, Harris B, Varticovski L, Sportelli P, Leleu X, Anderson KC, Richardson PG. Clinical and translational studies of a phase II — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | Response will include complete remission, partial remission (PR), and minimal response (MR) using serum protein electrophoresis. Response will also be assessed by IgM using nephelometry. | Every 4 weeks | |
Secondary | Safety | Adverse events will be assessed at each visit and graded according to the National Cancer Institute Common Toxicity Criteria (version 3.0) from the first dose until 30 d after the last dose of perifosine. | Every 4 weeks | |
Secondary | Time to progression | This will be calculated using Kaplan-Meier methodology. | Every 4 weeks | |
Secondary | Progression free survival | This will be calculated using Kaplan-Meier methodology. | Every 4 weeks | |
Secondary | Duration of response | This will be reported among responding patients. | Every 4 weeks |
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
|