Phase 4
N=39
Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib
Chronic Phase Chronic Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01660906 ↗Enrolled (actual)
39
Serious AEs
28.2%
Results posted
Nov 2016
Primary outcome: Primary: The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment — 91; 2; 27; 1 adverse event(s)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dasatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment |
91; 2; 27; 1 | — |
| SECONDARY Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib |
-1.35; -1.44; -1.06; -1.24; -1.28; -1.30 | — |
| SECONDARY Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib |
0.46; 2.86; 1.90; 1.43; 11.19; 12.62 | — |
| SECONDARY Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome |
37; 3; 34; 11; 3; 0 | — |
| SECONDARY The Percentage of Participants With at Least 1 Imatinib-related Grade 1 or Grade 2 Chronic Adverse Events (AEs) That Improved Without Worsening Within 3 Months of Switching to Dasatinib |
87.1 | — |
Summary
This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from imatinib to dasatinib.
Eligibility Criteria
Inclusion Criteria
- Patients with CML-CP patients achieving an optimal response to imatinib treatment with Grade 1 or 2 non-hematologic adverse events persisting for at least 2 months or recurring at least 3 times in the preceding 12 months, despite best supportive care
- Men and women with Chronic Myeloid Leukemia- Chronic Phase (CML-CP) Ph+ ≥ age 18
- Daily Eastern Co-Operative Group (ECOG) performance status = 0 - 2
- Patient willing and able to give informed consent
- Life expectancy > 6 months
- Adequate renal function
- Adequate hepatic function
Exclusion Criteria
- Patients who are pregnant or breast feeding
- Men whose partner is unwilling to avoid pregnancy.
- Previous treatment with any other tyrosine-kinase inhibitor (TKI), except for imatinib
- Current grade 3 or 4 imatinib related adverse event
- Prior documented T315I mutation
- Prior diagnosis of accelerated phase or blast crisis CML
- Previous loss of complete hematologic response (CHR) or major cytogenetic response (MCyR) on imatinib
- Concurrent medical condition of uncontrolled infection, cardiovascular diseases of cardiac failure, congenital long QT syndrome, ventricular arrhythmias, prolonged QT interval, second or third degree heart block, uncontrolled angina, myocardial infarction (MI) in the last 6 months, uncontrolled hypertension, pulmonary arterial hypertension, pleural or pericardial effusions, or history of bleeding disorder
Data sourced from ClinicalTrials.gov (NCT01660906). 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.