Clinical trial · Interventional
Dasatinib in Relapsed Chronic Lymphocytic Leukemia
Phase II Study of Dasatinib (BMS-354825) in Relapsed Chronic Lymphocytic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dasatinib treatment
- description
- All patients were treated with dasatinib pills by mouth as treatment.
- interventionNames
- Drug: Dasatinib
Primary outcomes (1)
- measure
- Overall Objective Response
- timeFrame
- 2 years
- description
- Overall objective response rate in terms of complete response, nodular partial response, and partial response to treatment. Objective response is when a biopsy shows. In general response is defined as the following (not complete criteria): Complete response (CR) requires all of the following for a period of at least 2 months: * Absence of lymphadenopathy * No hepatomegaly or splenomegaly * Absence of constitutional symptoms * Normal complete blood count Nodular partial response (nPR): Met the criteria for CR, but had residual bone marrow biopsy nodules as the only evidence of disease Partial response (PR): requires at least the following: * 50% decrease in peripheral blood lymphocyte count * 50% reduction in lymphadenopathy * 50% reduction in the size of the liver and/or spleen
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available