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NCT00936611 · ClinicalTrials.gov registry record · Phase 2
LBH589 in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT00936611: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT00936611 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00936611, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
The purpose of this research study is to assess the overall response rate of LBH589 in patients with relapsed or refractory Waldenstrom's Macroglobulinemia. LBH589 is a newly discovered compound that has killed Waldenstrom cells in laboratory studies, however, it is not known if LBH589 will show the same activity in people with Waldenstrom's Macroglobulinemia. This drug has been used in research for the treatment of other types of cancer, such as multiple myeloma.
Primary Outcome
Overall response rate is percentage of participants with complete (CR), very good partial (VGPR), partial (PR), or minimal response (MR) as best response during treatment. CR * Disappearance of monoclonal protein by immunofixation * No histologic evidence of bone marrow involvement * Resolution of any adenopathy/organomegaly (confirmed by CT scan), or signs or symptoms attributable to WM. * Second immunofixation required for confirmation. VGPR -At least 90% reduction of serum monoclonal IgM
Interventions
- DRUG LBH589
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2009-07 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
What the finished NCT00936611 record still lists
NCT00936611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which LBH589 is the first listed.
NCT00936611 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00936611 about?
NCT00936611 is a clinical study titled "LBH589 in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia". The purpose of this research study is to assess the overall response rate of LBH589 in patients with relapsed or refractory Waldenstrom's Macroglobulinemia. LBH589 is a newly discovered compound that has killed Waldenstrom cells in laboratory studies, however, it is not known if LBH589 will show the...
What is the current status of trial NCT00936611?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2009-07. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00936611?
The interventions under investigation include: LBH589 (DRUG).
Who is sponsoring clinical trial NCT00936611?
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 NCT00936611's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 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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