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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00777036
First received: October 21, 2008
Last updated: July 23, 2014
Last verified: January 2014
  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 2

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:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    MCyR rate will be measured every 3 months during the first two years and yearly thereafter for up to 5 years after discontinuation of study therapy

  • Complete Hematologic Response (CHR) rate defined as the proportion of all treated subjects who achieve a confirmed CHR on study [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    CHR rate will be measured every 3 months during the first two years and yearly thereafter for up to 5 years after discontinuation of study therapy

  • Complete Cytogenetic Response (CCyR) rate, defined as the proportion of all treated subjects who achieve a CCyR on study [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    CCyR rate will be measured every 3 months during the first two years and yearly thereafter for up to 5 years after discontinuation of study therapy


Secondary Outcome Measures:
  • Complete Hematologic Response (CHR) rate for Cohort #1 and Cohort #3, defined as the proportion of all treated subjects who achieve a confirmed CHR on study [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    CHR rate will be measured every 3 months during the first two years and yearly thereafter for up to 5 years after discontinuation of study therapy

  • Major Cytogenetic Response (MCyR) rate for Cohort #2, defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    MCyR rate will be measured every 3 months during the first two years and yearly thereafter for up to 5 years after discontinuation of study therapy

  • Rates of best cytogenetic response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Proportion of subjects with best cytogenetic response will be measured every 3 months during the first two years and yearly thereafter for up to 5 years after discontinuation of study therapy

  • Time to Major Cytogenetic Response (MCyR) and duration of MCyR [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Duration of MCyR will be measured every 3 months during the first two years and yearly thereafter for up to 5 years after discontinuation of study therapy

  • Time to Complete Cytogenetic Response (CCyR) and duration of CCyR [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Duration of CCyR rate will be measured every 3 months during the first two years and yearly thereafter for up to 5 years after discontinuation of study therapy

  • Time to Complete Hematologic Response (CHR) and duration of CHR [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Duration of CHR will be measured every 3 months during the first two years and yearly thereafter for up to 5 years after discontinuation of study therapy

  • Progression-free Survival (PFS), is defined as time from the first dosing date until the time Progressive Disease (PD) is first documented by the investigator or death [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Disease free survival (DFS) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    DFS is defined as time from CCyR for subjects with newly diagnosed chronic phase CML and for subjects with chronic phase CML who are resistant or intolerant to imatinib (cohort 3 and cohort 1), and as time from CHR for subjects with advanced phase CML and PH + ALL (cohort 2) until the time progression is first documented by the investigator or death from any cause

  • Overall Survival (OS) is defined as time from the first dosing date until the time of death [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Rates of major and complete molecular response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Major and complete molecular response rate will be measured every 3 months during the first two years and yearly thereafter for up to 5 years after discontinuation of study therapy


Estimated Enrollment: 139
Study Start Date: February 2009
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: CP-CML

Dasatinib 60 mg/m² tablet every day (QD) [with a maximum dose of 100 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

OR

Dasatinib 72 mg/m² powder for oral suspension (PFSO) QD [with a maximum dose of 120 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

Drug: Dasatinib
Other Name: Sprycel (BMS-354825)
Experimental: Cohort 2: Ph+ALL or AP- or BP-CML

Dasatinib 80 mg/m² tablet QD [with a maximum dose of 140 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

OR

Dasatinib 96 mg/m² PFSO QD [with a maximum dose of 170 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

Drug: Dasatinib
Other Name: Sprycel (BMS-354825)
Experimental: Cohort 3: Newly diagnosed, treatment naïve CP-CML

Dasatinib 60 mg/m² tablet QD [with a maximum dose of 100 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

OR

Dasatinib 72 mg/m² PFSO QD [with a maximum dose of 120 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

Drug: Dasatinib
Other Name: Sprycel (BMS-354825)

Detailed Description:

Cohort 2 is closed to enrollment

  Eligibility

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 83 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: 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: July 23, 2014
Health Authority: United States: Food and Drug Administration
Brazil: National Health Surveillance Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Russia: Ministry of Health 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 July 24, 2014