Phase II Trial of Oral LBH 589, a Novel Histone Deacetylase (HDAC) Inhibitor, in Relapsed or Refractory Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma
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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Desired 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.
8 weeks (2 cycles) unless treatment continues due to partial or complete response
No
Celeste Bello, M.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
MCC-15971
NCT01090973
March 2010
March 2011
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |