Oral LBH589 in Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL)

Non-Hodgkin's Lymphoma Clinical Trial

Official title: Phase II Trial of Oral LBH 589, a Novel Histone Deacetylase (HDAC) Inhibitor, in Relapsed or Refractory Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma

Status Terminated

Clinical Trial Summary

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).

Clinical Trial Description

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 ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

• NCT number: NCT01090973
• Study type: Interventional
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Status: Terminated
• Phase: Phase 2
• Start date: March 2010
• Completion date: March 2011