Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Leukemia Clinical Trial

— START rollover  

Official title:

Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982488
• Other study ID #: CA180-188
• Secondary ID: 2007-003624-37
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2009
• Last updated: December 16, 2015
• Start date: October 2007
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesGermany: Ministry of HealthPeru: Instituto Nacional de SaludArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaSwitzerland: Federal Office of Public HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyBrazil: National Health Surveillance AgencyKorea: Food and Drug AdministrationBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentFinland: National Advisory Board on Health Care EthicsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsIreland: Irish Medicines BoardSouth Africa: Medicines Control CouncilThailand: Food and Drug AdministrationRussia: Ministry of Health of the Russian FederationBrazil: Ethics CommitteeFinland: Finnish Medicines AgencyFinland: Data Protection BoardThailand: Ministry of Public HealthPoland: National Institute of MedicinesPoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria

• Signed written informed consent

• Received treatment in protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017, or CA180-039

• Received clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator

• Men and women, ages 18 and older

Key Exclusion Criteria

• A serious uncontrolled medical disorder or active infection that would impair the ability of the patient to receive protocol therapy

• Dementia or altered mental status that would prohibit the understanding or rendering of informed consent

• Patients currently taking drugs, including but not limited to quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine, which are generally accepted to have a risk of causing Torsades de Pointes

• Patients taking medications known to be potent CYP3A4 inhibitors (ketoconazole, ritonavir) or inducers (rifampin, efavirenz)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abnormal Karyotype
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Philadelphia Chromosome

Intervention

Drug:
• Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.
• Imatinib
Imatinib was supplied as 100- and 400-mg tablets.

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Australia	Local Institution	Adelaide	South Australia
Belgium	Local Institution	Mont-godinne
Brazil	Local Institution	Campinas	San Paulo
Brazil	Local Institution	Curitiba	Parana
Brazil	Local Institution	Rio de Janeiro
Brazil	Local Institution	Sao Paulo
Brazil	Local Institution	Sao Paulo
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Toronto	Ontario
Finland	Local Institution	Helsinki
France	Local Institution	Lille
France	Local Institution	Lyon Cedex 03
France	Local Institution	Nantes
France	Local Institution	Paris
France	Local Institution	Pessac
France	Local Institution	Poitiers Cedex
France	Local Institution	Strasbourg
Germany	Local Institution	Hamburg
Germany	Local Institution	Leipzig
Germany	Local Institution	Mannheim
Hungary	Local Institution	Budapest
Ireland	Local Institution	Dublin 8	Dublin
Israel	Local Institution	Ramat-gan
Italy	Local Institution	Bologna
Italy	Local Institution	Napoli
Italy	Local Institution	Orbassano (to)
Italy	Local Institution	Roma
Korea, Republic of	Local Institution	Jeollanam-do
Korea, Republic of	Local Institution	Seoul
Norway	Local Institution	Trondheim
Peru	Local Institution	Lima
Peru	Local Institution	Lima
Poland	Local Institution	Katowice
Poland	Local Institution	Krakow
Poland	Local Institution	Lodz
Poland	Local Institution	Lublin
Poland	Local Institution	Warsaw
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	St.petersburg
South Africa	Local Institution	Groenkloof	Gauteng
South Africa	Local Institution	Parktown	Gauteng
Spain	Local Institution	Barcelona
Sweden	Local Institution	Gothenburg
Sweden	Local Institution	Lund
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Umea
Sweden	Local Institution	Uppsala
Switzerland	Local Institution	Basel
Thailand	Local Institution	Bangkok
United Kingdom	Local Institution	Glasgow	Scotland
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Newcastle	Tyne And Wear
United States	Pacific Cancer Medical Center Inc	Anaheim	California
United States	University Of Michigan Medical Center	Ann Arbor	Michigan
United States	Dana Faber Cancer Institute	Boston	Massachusetts
United States	University Of Chicago	Chicago	Illinois
United States	Ut Southwestern Medical Center At Dallas	Dallas	Texas
United States	Wayne State University	Detroit	Michigan
United States	John Theurer Cancer Center	Hackensack	New Jersey
United States	The University Of Texas Md Anderson Cancer Center	Houston	Texas
United States	Central Indiana Cancer Centers	Indianapolis	Indiana
United States	Loma Linda University Cancer Center	Loma Linda	California
United States	Ucla Department Of Medicine	Los Angeles	California
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health & Sci Univ	Portland	Oregon
United States	Stanford University School Of Medicine	Stanford	California
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida
United States	Kaiser Permanente Medical Center	Vallejo	California
United States	University Of Kansas Medical Center	Westwood	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Finland,  France,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Korea, Republic of,  Norway,  Peru,  Poland,  Russian Federation,  South Africa,  Spain,  Sweden,  Switzerland,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest	AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug.	Day 1 of treatment through a maximum of 82 months + 30 days	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form