|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00438854 |
|
Date of registration:
|
20/02/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Dasatinib in Relapsed Chronic Lymphocytic Leukemia
|
|
Scientific title:
|
Phase II Study of Dasatinib (BMS-354825) in Relapsed Chronic Lymphocytic Leukemia |
|
Date of first enrolment:
|
December 2006 |
|
Target sample size:
|
15 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00438854 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Philip Amrein, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Massachusetts General Hospital |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 18 years of age or older
- CLL/SLL with cells positive by flow cytometry (or immunostaining) for CD19, CD23 and
CD. Patients may be CD23 negative as long as they are also cyclin D1 negative.
- Must have failed at least 1 prior fludarabine containing regimen or have failed at
least 2 non-fludarabine containing regimens or have a contraindication to fludarabine
use
- ECOG performance status of 2 or better
- Adequate organ function to tolerate chemotherapy
- Adequate method of contraception
Exclusion Criteria:
- Pregnant or breast-feeding women
- Uncontrolled angina within 3 months
- Diagnosed or suspected congenital long QT syndrome
- History of clinically significant ventricular arrhythmias
- Prolonged QTc interval on pre-entry electrocardiogram
- Uncontrolled hypertension
- Drugs that are generally accepted to have a risk of causing Torsades de Pointes
- Patient known to be HIV positive
- Known significant bleeding disorder unrelated to CLL
- Drugs that interfere with platelet function or coagulation must be stopped at least 7
days prior to entry
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Lymphocytic Leukemia
|
|
Intervention(s)
|
|
Drug: Dasatinib
|
|
Primary Outcome(s)
|
|
Overall Objective Response Rate in Terms of Complete Response, Nodular Partial Response, and Partial Response to Treatment With Dasatinib for Patients With CLL/SLL (Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma).
[Time Frame: 2 years]
|
|
Secondary Outcome(s)
|
|
and to Correlate LYN Kinase Activity With Response in Study Subjects.
[Time Frame: 2 years]
|
|
Duration of Overall Response for All Patients
[Time Frame: TBD]
|
|
The Complete Response Rate Will Also be Evaluated
[Time Frame: TBD]
|
|
to Define the Spectrum of Toxicities of This Treatment in This Patient Population
[Time Frame: 2 years]
|
|
to Determine the Progression-free Survival and Overall Survival
[Time Frame: TBD]
|
|
Secondary ID(s)
|
|
06-211
|
|
CA 180-045
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|