A Phase II Study of Dasatinib Therapy in Children and Adolescents with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia or with Ph+ Leukaemias Resistant or Intolerant to Imatinib
- Conditions
- Leukemias10024324
- Registration Number
- NL-OMON47600
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
1. Diagnosis:
Cohort 1: Subjects must have Ph+ CP-CML
Cohort 2: Subjects must have Ph+ ALL or Ph+ AP- or BP-CML
Cohort 3a: newly diagnosed treatment-naive chronic phase chronic myelogenous
leukemia (CP-CML)
Cohort 3b: sub-cohort of 30 newly diagnosed treatment-naive chronic phase
chronic myelogenous leukemia (CP-CML), who will receive dasatinib powder for
oral suspension (PFOS), Subjects in Cohorts 1 and 2 must have proven resistance
or intolerance to imatinib
(2) Lansky or Karnofsky scale > 50
(3) Life expectancy * 12 weeks
(4) Subjects must have recovered to baseline or Grade 1 (NCI CTCAE, version
3.0) from the toxicities (except alopecia) resulting from recent therapies,
including chemotherapy, hormonal therapy, immunotherapy, biological therapy or
investigational product and radiation therapy
(5) Serum Na, K, Na, HC03, Mg, P and Ca levels within institutional normal
limits and AST, ALT, bilirubin, serum creatinine * Grade 2 (NCI CTCAE, Version
3.0)
(1) Subjects for whom potentially-curative therapy is available, including
hematopoietic stem-cell transplantation (HSCT)
(2) Symptomatic central nervous system (CNS) involvement (except if signs and
symptoms are from isolated leptomeningeal disease)
(3) Isolated extramedullary disease, with < 5% blasts in bone marrow
(4) Any serious uncontrolled medical disorder that would impair the ability of
the subject to receive protocol therapy
(5) Prior therapy with dasatinib
(6) Any investigational agent or any other anti-cancer agent within 14 days
prior to treatment start. Imatinib mesylate may be continued up to 7 days
before treatment start, or, in the presence of rising peripheral blast cells,
imatinib may be continued up to 2 days before treatment start. If required for
control of peripheral blast cells, hydroxyurea, corticosteroids,
6-mercaptopurine or 6-thioguanine may be given up to 2 days before treatment
start.
(7) Subjects requiring ongoing medications which may:
-Have a known risk of causing QTc prolongation
-Irreversibly inhibit platelet function, or anticoagulants (Does not apply to
low-dose heparin for prophylaxis or to heparin flushes for i.v. lines)
(8) Sexually active females of child-bearing potential that are unwilling or
unable to use an acceptable method to avoid pregnancy.
(9) Sexually active fertile malesnot using effective birth control, if their
partners are of child-bearing potential.
(10) Cohort 3a and b: no prior chemotherapy, immunotherapy, or radiotherapy for
CML with the exception of hydroxyurea
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to estimate the rate of response to<br /><br>dasatinib in children and adolescents with certain types of leukaemia, whose<br /><br>disease is either resistant to, intolerant to, or relapsed after previous<br /><br>imatinib therapy or are newly diagnosed and treatment naïve.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives of this study are: to assess safety and tolerability<br /><br>in the above patient groups; to evaluate additional measures of<br /><br>response/effectiveness: best cytogenetic and haematological response rates;<br /><br>time to response; duration of response; progression-free survival; overall<br /><br>survival; rates of complete and major molecular response (response at the DNA<br /><br>level); to look at Bcr-abl mutations at baseline, at progression or end of<br /><br>treatment and to explore the role of mutations as predictors of response.</p><br>