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Phase II Trial of Oral LBH 589, a Novel Histone Deacetylase (HDAC) Inhibitor, in Relapsed or Refractory Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma
The purpose of the study is to find out the effects and the safety of an investigational study drug called LBH589 when given to people with relapsed or refractory chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL).
Details
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 1 |
| Start date | 2010-03 |
| Completion | 2011-03 |
Conditions
- Non-Hodgkin's Lymphoma
Interventions
- LBH589
Primary outcomes
- Number of Participants With Desired Response — 8 weeks (2 cycles) unless treatment continues due to partial or complete response
Investigators intended to assess the rate of overall and complete response by World Health Organization (WHO) classification in patients with relapsed or refractory aggressive mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). WHO Performance Scale Measures levels of patient capability: 0 Normal activity; 1 Symptoms, but nearly fully ambulatory; 2 Some bed time, but needs to be in bed \<50% of normal daytime; 3 Needs to be in bed \>50% of normal daytime; 4 Unable to get out of bed.
Countries
United States