Clinical trial NCT01090973
Conditions: Non-Hodgkin's Lymphoma
Keywords: relapsed refractory CLL chronic lymphocytic leukemia MCL mantle cell lymphoma
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2010-03-01; Completion date: 2011-03-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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).

Detailed 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

Arms: arm 1: LBH589 will be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 \& 5, then 8, 10 \&12, then 15, 17 \& 19, then 22, 24 \& 26.
Interventions: intervention 1: LBH589
Intervention descriptions: intervention 1: The LBH589 capsule(s) should be swallowed by mouth with a glass of water (8 ounces noncarbonated) in the morning. The daily dose of LBH589 should be taken at approximately the same time each day. Patients should avoid eating grapefruit, Seville (sour) orange or drinking grapefruit juice or Seville orange juice during the study.

After 2 cycles of treatment, if patients do not demonstrate a partial response or complete response (all of the tumor is gone) to the therapy they will be removed from the study. If patients do obtain a partial (the tumor(s) have decreased in size or number but there are still tumors present) or complete response then treatment will continue until their disease progresses.

Protocol documents: