A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00777036

Purpose

The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

Condition	Intervention	Phase
Leukemia	Drug: Dasatinib	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib

Resource links provided by NLM:

MedlinePlus related topics: Leukemia

Drug Information available for: Imatinib Imatinib mesylate Dasatinib

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

The major cytogenetic response (MCyR) rate to dasatinib therapy in children and adolescents with CP-CML subjects who prove resistant to or intolerant to imatinib [ Time Frame: Every 3 months during the first two years. Yearly thereafter and at the end of protocol therapy ] [ Designated as safety issue: Yes ]
The complete hematologic response (CHR) rate in children and adolescents with Ph+ ALL, AP-CML and BP-CML, who are resistant, intolerant to, or relapse after prior imatinib therapy [ Time Frame: Every week for the first eight weeks. Then every 3 months during the first two years. Every three months thereafter and at the end of protocol therapy ] [ Designated as safety issue: Yes ]
The complete cytogenetic response (CCyR) rate to dasatinib therapy in children and adolescents with newly diagnosed CP-CML who are treatment-naive [ Time Frame: Every 3 months during the first two years. Yearly thereafter and at the end of protocol therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the safety and tolerability of dasatinib in children and adolescents treated with dasatinib for relapsed or refractory Ph+ leukemias [ Time Frame: Every week for the first eight weeks. Then every 3 months during the first two years. Every three months thereafter and at the end of protocol therapy. ] [ Designated as safety issue: Yes ]
To assess the safety and tolerability of dasatinib in children and adolescents with newly diagnosed Ph+ CP-CML who are treatment-naive [ Time Frame: Every week for the first eight weeks. Then every 3 months during the first two years. Every three months thereafter and at the end of protocol therapy. ] [ Designated as safety issue: No ]
To evaluate additional measures of efficacy in children and adolescents with newly diagnosed CP-CML or subjects with relapsed or refractory Ph+ leukemias treated on a given regimen of dasatinib including: -best cytogenetic & hematological response rates [ Time Frame: Every 3 months during the first two years. Then every three months thereafter and at the end of protocol therapy ] [ Designated as safety issue: No ]
To evaluate additional measures of efficacy in children and adolescents with newly diagnosed CP-CML or subjects with relapsed or refractory Ph+ leukemias treated on a given regimen of dasatinib including: - time to response and duration of response [ Time Frame: Every week for the first eight weeks. Then every 3 months during the first two years. Every three months thereafter and at the end of protocol therapy. ] [ Designated as safety issue: No ]
To evaluate additional measures of efficacy in children and adolescents with newly diagnosed CP-CML or subjects with relapsed or refractory Ph+ leukemias treated on a given regimen of dasatinib including: - disease free survival (DFS) [ Time Frame: Every week for the first eight weeks. Then every 3 months during the first two years. Every three months thereafter and at the end of protocol therapy. ] [ Designated as safety issue: No ]
To evaluate additional measures of efficacy in children and adolescents with newly diagnosed CP-CML or subjects with relapsed or refractory Ph+ leukemias treated on a given regimen of dasatinib including: - progression-free survival (PFS) [ Time Frame: Every week for the first eight weeks. Then every 3 months during the first two years. Every three months thereafter and at the end of protocol therapy. ] [ Designated as safety issue: No ]
To evaluate additional measures of efficacy in children and adolescents with newly diagnosed CP-CML or subjects with relapsed or refractory Ph+ leukemias treated on a given regimen of dasatinib including: overall survival (OS) [ Time Frame: Every week for the first eight weeks. Then every 3 months during the first two years. Every three months thereafter and at the end of protocol therapy. ] [ Designated as safety issue: No ]
To evaluate additional measures of efficacy (children & adolescents) with newly diagnosed CP-CML or subjects with relapsed or refractory Ph+ leukemias treated on a given regimen of dasatinib: - rates of complete (CMR) and major (MMR) molecular response [ Time Frame: Every 3 months during the first two years, then at every 6 months, at progression or end of treatment ] [ Designated as safety issue: Yes ]
To describe the spectrum of the BCR-ABL mutations [ Time Frame: At baseline, every 3 months during the first two years, then at every 6 months, at progression or end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	109
Study Start Date:	March 2009
Estimated Study Completion Date:	September 2016
Estimated Primary Completion Date:	September 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort 1: CP-CML	Drug: Dasatinib Tablets / Oral Suspension, Oral, Dose escalation allowed, 60 mg/m² QD with a maximum dose of 100 mg QD {max dose of 120 mg QD if BSA >1.7m²}, once daily, minimum of 24 months, may continue as long as deriving clinical benefit Other Names: Sprycel BMS-354825
Experimental: Cohort 2: Ph+ ALL or AP- or BP-CML	Drug: Dasatinib Tablets / Oral Suspension, Oral, Dose escalation allowed, 80 mg/m² QD with a maximum dose of 140 mg QD {max dose of 170 mg QD if BSA >1.7m²}, once daily, minimum of 24 months, may continue as long as deriving clinical benefit Other Names: Sprycel BMS-354825
Experimental: Cohort 3: Newly diagnosed, treatment naïve CP-CML	Drug: Dasatinib Tablets / Oral Suspension, Oral, Dose escalation allowed, 60 mg/m² QD with a maximum dose of 100 mg QD {max dose of 120 mg QD if BSA >1.7m²}, once daily, minimum of 24 months, may continue as long as deriving clinical benefit Other Names: Sprycel BMS-354825

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

CP-CML who prove resistant or intolerant to imatinib (cohort #1)
Ph+ ALL, AP-CML, or BP-CML who are resistant or intolerant to or who relapse after imatinib therapy (cohort #2)
Newly diagnosed, treatment naive CP-CML (cohort #3)
Lansky or Karnofsky scale > 50
Life expectancy ≥ 12 weeks
Adequate hepatic and renal function
Written informed consent

Exclusion Criteria:

Eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation
Symptomatic CNS involvement (other than signs and symptoms caused by leptomeningeal disease)
Isolated extramedullary disease
Prior therapy with dasatinib

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777036

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 85 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00777036 History of Changes
Other Study ID Numbers:	CA180-226, 2008-002260-33
Study First Received:	October 21, 2008
Last Updated:	February 2, 2012
Health Authority:	United States: Food and Drug Administration; Brazil: National Health Surveillance Agency; France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); Russia: Ministry of Health and Social Development of the Russian Federation; Spain: Ministry of Health and Consumption; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bristol-Myers Squibb:

Leukemia, Pediatric

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

Imatinib
Dasatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012