Phase 2
N=15
Dasatinib in Relapsed Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00438854 ↗Enrolled (actual)
15
Serious AEs
66.7%
Results posted
Oct 2012
Primary outcome: Primary: Overall Objective Response — 3 participants who responded
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dasatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Objective Response |
3 | — |
| SECONDARY Complete Response Rate |
— | — |
| SECONDARY Median Time to Disease Progression |
7.5 | — |
| SECONDARY Median Overall Survival |
27 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00438854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.