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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).
Response Assessment for Mantle Cell Lymphoma Based on the International Workshop to Standardize Response Criteria to non-hodgkin's lymphoma (NHL) (Cheson, JCO 1999) a complete hematologic remission will be defined as the following: * Disappearance of all evidence of disease. * Any positron emission tomography (PET)+ mass prior to therapy must be PET negative after treatment. * No palpable spleen or liver * If bone marrow involvement prior to therapy, must document clear bone marrow. Partial response will be defined as: * No new areas of disease on clinical exam and regression of previous areas of disease * Greater than or equal to 50% decrease in the size of prior disease areas per measurement on computed tomography (CT) scan * No new PET+ areas on PET scan * No increase in size of liver or spleen Response Assessment for CLL Using the National Cancer Institute (NCI) criteria, a complete hematologic remission will be defined as having the following present for 2 or more months: * Absence of symptoms attributable to CLL * Normal findings on physical examination * Absolute lymphocyte count \<4000/microL * Absolute neutrophil count (ANC) \>1500/microL * Platelet count \>100,000/microL * Hemoglobin concentration \>11 g/dL (untransfused) * Bone marrow lymphocytosis \<30 percent * No nodules (lymphoid aggregates) on bone marrow biopsy A partial response per the NCI criteria will be defined as having the following for 2 or more months: * A reduction in previously enlarged nodes, spleen, and liver by at · least 50 percent and * Absolute neutrophil count ≥1500/microL or * Platelet count ≥100,000/microL or * Hemoglobin concentration ≥11 g/dL or * 50 percent improvement over pretherapy reductions in hemoglobin concentration and/or platelet count
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Start Date
March 1, 2010
Primary Completion Date
March 1, 2011
Completion Date
March 1, 2011
Last Updated
December 16, 2013
1
ACTUAL participants
LBH589
DRUG
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
NCT06667687
NCT05623982
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03314974