Clinical trial NCT01660906: 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
Official title: A 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Phase Chronic Myeloid Leukemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-08-09
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment
timeFrame: 3 months after switch to dasatinib
Secondary outcomes:
measure: 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
timeFrame: Baseline to 3, 6, 12 months
measure: 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
timeFrame: Baseline to 6, 12 months
measure: 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
timeFrame: Date of first dose to 30 post last dose of study drug, an average of 3 years
measure: 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
timeFrame: 3 months
Other outcomes:
measure: Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib
timeFrame: 6 and 12 months
Locations:
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center
state: California
city: Southington
country: United States
facility: Cancer Center Of Central Connecticut
state: Connecticut
city: Baltimore
country: United States
facility: St. Agnes Healthcare, Inc.
state: Maryland
city: Sylvania
country: United States
facility: Promedica Hematology & Oncology Assoicates
state: Ohio
city: Houston
country: United States
facility: The University Of Texas Md Anderson Cancer Center
state: Texas
city: Creteil Cedex
country: France
facility: Local Institution
city: Lille CEDEX
country: France
facility: Local Institution
city: Pierre Benite cedex
country: France
facility: Local Institution
city: Pringy Cedex
country: France
facility: Local Institution
city: Vandoeuvre les Nancy
country: France
facility: Local Institution
city: Jena
country: Germany
facility: Local Institution
city: Koln
country: Germany
facility: Local Institution
city: Lubeck
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Rostock
country: Germany
facility: Local Institution
city: Catania
country: Italy
facility: Local Institution
city: Firenze
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: