Ignite Creation Date:
2024-05-05 @ 10:22 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01090973
Status:
TERMINATED
Last Update Posted:
2013-12-16
First Post:
2010-03-18
Brief Title:
Oral LBH589 in Relapsed or Refractory Chronic Lymphocytic Leukemia CLL and Mantle Cell Lymphoma MCL
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
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
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pharmaceutical company request
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-hodgkins 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 4000microL
Absolute neutrophil count ANC 1500microL
Platelet count 100000microL
Hemoglobin concentration 11 gdL 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 1500microL or
Platelet count 100000microL or
Hemoglobin concentration 11 gdL or
50 percent improvement over pretherapy reductions in hemoglobin concentration andor platelet count
Based on the International Workshop to Standardize Response Criteria to non-hodgkins 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 4000microL
Absolute neutrophil count ANC 1500microL
Platelet count 100000microL
Hemoglobin concentration 11 gdL 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 1500microL or
Platelet count 100000microL or
Hemoglobin concentration 11 gdL or
50 percent improvement over pretherapy reductions in hemoglobin concentration andor platelet count
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CLBH589B25T | OTHER | Novartis | None |
| IRB Pro00000102 | OTHER | None | None |