Phase 2
N=37
Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia
Waldenstrom's Macroglobulinemia
Bottom Line
View on ClinicalTrials.gov: NCT00422656 ↗Enrolled (actual)
37
Serious AEs
37.8%
Results posted
Feb 2012
Primary outcome: Primary: Overall Response (OR) Rate — 38 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Perifosine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response (OR) Rate |
38 | — |
| SECONDARY Time to Progression (TTP) |
12.6 | — |
| SECONDARY Progression Free Survival (PFS) |
12.6 | — |
| SECONDARY Treatment-Related Grade 3-4 Adverse Event Rate |
35 | — |
Summary
Waldenström's Macroglobulinemia (lymphoplasmacytic lymphoma, WM) remains incurable with limited therapeutic options and notably absent FDA approved therapy with any WM indication. Therefore, there is a need to identify new therapeutic agents for WM patients both in the upfront and relapsed/refractory setting. The purpose of this research study is to assess the efficacy of perifosine in patients with relapsed or refractory WM.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- 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 paraprotein with a minimum IgM level of equal to or greater than 2 times the ULN and over 10% of lymphoplasmacytic cells in bone marrow
- ECOG Performance Status 0,1, or 2
- Laboratory values as described in the protocol
- Life expectancy of greater than 12 weeks
Exclusion Criteria
- Uncontrolled infection
- Other active malignancies
- CNS involvement
- Cytotoxic chemotherapy less than 3 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks prior to registration.
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
- Pregnant or nursing women
- Known to be HIV positive
- Radiation therapy less than 2 weeks prior to registration
Data sourced from ClinicalTrials.gov (NCT00422656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.