Phase 2
N=19
Dasatinib in Treating Patients With Chronic Lymphocytic Leukemia
Refractory Chronic Lymphocytic Leukemia · Stage I Chronic Lymphocytic Leukemia · Stage II Chronic Lymphocytic Leukemia · Stage III Chronic Lymphocytic Leukemia · Stage IV Chronic Lymphocytic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01441882 ↗Enrolled (actual)
19
Serious AEs
61.5%
Results posted
Feb 2018
Primary outcome: Primary: The Number of Participants With In Vitro Dasatinib Sensitivity in Predicting Clinical Activity — 5; 4; 4; 0 Participants — p=0.0106
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dasatinib (Drug); Laboratory Biomarker Analysis (Other); Pharmacological Study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- OHSU Knight Cancer Institute
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With In Vitro Dasatinib Sensitivity in Predicting Clinical Activity |
5; 4; 4; 0 | 0.0106 sig |
| SECONDARY Objective Response |
0; 2; 2; 8; 1 | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Progression-free Survival |
— | — |
| SECONDARY Incidence of Adverse Events (Number of Participants Affected) |
8 | — |
Summary
This phase II trial studies how well dasatinib works in treating patients with chronic lymphocytic leukemia (CLL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Eligibility Criteria
Inclusion Criteria
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal information
- Eastern Cooperative Oncology Group (ECOG) = = 65 who are not candidates for or do not want to pursue aggressive chemotherapy treatment
- Have indications for treatment or evidence of progressive disease defined as follows (1996 NCI working group):
- Massive or progressive splenomegaly
- Massive lymph nodes (>= 10 cm), nodal clusters (>= 10 cm), or progressive lymphadenopathy
- Symptomatic anemia and/or thrombocytopenia (Rai stages III or IV disease)
- Autoimmune hemolytic anemia and/or thrombocytopenia that are poorly responsive to corticosteroid therapy
- Progressive lymphocytosis with increase in lymphocyte count of >= 50% over a 2-month period or an anticipated doubling time of 30,000
- Ability to take oral medication (dasatinib must be swallowed whole)
- No clinically significant infections as determined by the investigator
- Normal corrected QT (QTc) interval ( = 50,000/mm^3
Exclusion Criteria
- Patients may not receive concurrent chemotherapy, radiotherapy, or immunotherapy
- Pleural or pericardial effusion of any grade
- Uncontrolled angina, > New York Heart Association (NYHA) class III congestive heart failure or myocardial infarction (MI) within 6 months prior to study enrollment
- Diagnosed congenital long QT syndrome
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
- Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
- Subjects who are detained or imprisoned are not eligible
- History of significant bleeding disorder unrelated to cancer, including:
- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
- Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
- May not take concomitant medications that are generally accepted to have a risk of causing Torsades de Pointes including: (patients must discontinue drug 7 days prior to starting dasatinib)
- Quinidine, procainamide, disopyramide
- Amiodarone, sotalol, ibutilide, dofetilide
- Erythromycin, clarithromycin
- Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
- Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, sparfloxacin, lidoflazine
- Patients already taking other CYP inducers or inhibitors other than those listed above are eligible for the study only after principal investigator (PI) review; dose adjustments and/or monitoring of drug levels where applicable will be made as needed by the PI after consultation with pharmacy
- Women who:
- Are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or
- Have a positive pregnancy test at baseline, or
- Are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT01441882). 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.