Dasatinib in Relapsed Chronic Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

The purpose of this research study is to see if Dasatinib is effective and safe to give to people with relapsed chronic lymphocytic leukemia (CLL) and to determine the effects of the drug on LYN kinase activity in blood and bone marrow. Recent research shows that a key enzyme in CLL cells is responsible for cell survival. This enzyme is called LYN kinase. Laboratory studies show that inhibition of LYN kinase in CLL cells results in the death to CLL cells. Dasatinib has the ability to inhibit LYN kinase and, therefore, should have some effect on CLL cells.

Key facts

Study ID

NCT00438854

Run by

Massachusetts General Hospital

People needed

15

Starts

2006-12-01

Expected to finish

2013-03-01

Last updated by the study team

2017-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.