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NCT00422656 · ClinicalTrials.gov registry record · Phase 2
Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT00422656: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT00422656 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00422656, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study 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.
Primary Outcome
OR rate is the percentage of patients achieving Complete Response (CR), Partial Response (PR) or Minimal Response (MR) during treatment based on criteria from the 2nd International Workshop on WM. (Weber D, Treon S, et al. Seminars in Oncology 2003). CR: Disappearance of serum monoclonal IgM protein (IgM M-protein) by immunofixation; no histologic evidence of bone marrow (BM) involvement, resolution of any adenopathy/organomegaly (confirmed by CT scan); PR: At least 50% reduction of IgM M-protei
Interventions
- DRUG Perifosine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2006-09 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
What the finished NCT00422656 record still lists
NCT00422656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Perifosine is the first listed.
NCT00422656 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00422656 about?
NCT00422656 is a clinical study titled "Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia". 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/refractor...
What is the current status of trial NCT00422656?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2006-09. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00422656?
The interventions under investigation include: Perifosine (DRUG).
Who is sponsoring clinical trial NCT00422656?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00422656's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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