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

NCT01660906 | Completed Phase 4 Results DMC

• 2 other identifiers: CA180-4002011-006180-21
• Study Type: interventional
• Target: 39
• Locations: 5 countries
• Sites: 22

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.

Conditions

Chronic Phase Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment

  Dasatinib treatment was administered and its impact on the imatinib-related Grade 1/2 adverse events was assessed. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Resolved, AE no longer present or resolution of imatinib-related chronic Grade 1 or Grade 2 non-hematologic AEs. Improved, AE grade reduced from Grade 2 to Grade 1. Unchanged, AE did not improve or worsen or no change in grade. Worsened, grade Increased.

  3 months after switch to dasatinib

Secondary Outcomes (4)

• 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

  Baseline to 3, 6, 12 months

• 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

  Baseline to 6, 12 months

• 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

  Date of first dose to 30 post last dose of study drug, an average of 3 years

• 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

  3 months

Other Outcomes (1)

• Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib

  6 and 12 months

Study Arms (1)

Dasatinib (100 mg)

EXPERIMENTAL

Drug: Dasatinib

Interventions

Dasatinib DRUG

tablets, oral, 100 mg, Once daily, Up to12 months on study,

Also known as: Sprycel

Dasatinib (100 mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (22)

Pacific Cancer Medical Center

Anaheim, California, 92801, United States

Location

Cancer Center Of Central Connecticut

Southington, Connecticut, 06489, United States

Location

St. Agnes Healthcare, Inc.

Baltimore, Maryland, 21229, United States

Location

Promedica Hematology & Oncology Assoicates

Sylvania, Ohio, 43560, United States

Location

The University Of Texas Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Local Institution

Créteil, 94010, France

Location

Local Institution

Lille, 59037, France

Location

Local Institution

Pierre-Bénite, 69495, France

Location

Local Institution

Pringy, 74374, France

Location

Local Institution

Vandœuvre-lès-Nancy, 54511, France

Location

Local Institution

Cologne, 50937, Germany

Location

Local Institution

Jena, 07747, Germany

Location

Local Institution

Lübeck, 23562, Germany

Location

Local Institution

Mannheim, 68169, Germany

Location

Local Institution

Rostock, 18055, Germany

Location

Local Institution

Catania, 95124, Italy

Location

Local Institution

Florence, 50134, Italy

Location

Local Institution

Napoli, 80131, Italy

Location

Local Institution

Roma, 00144, Italy

Location

Local Institution

Roma, 00161, Italy

Location

Local Institution

Torino, 10126, Italy

Location

Local Institution

Seoul, 137-701, South Korea

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 9, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 22, 2016
• Results First Posted: November 22, 2016

Record last verified: 2016-11

Locations

IT (6); FR (5); US (5); KR (1); DE (5)