Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL

Bristol-Myers Squibb

Overview

The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The efficacy of the drug in this kind of patients will also further be documented.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Chronic Myeloid Leukemia Acute Lymphoblastic Leukemia

Interventions

DasatinibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females, 18 or older * CP or AD CML or Ph+ ALL * Intolerant of resistant to imatinib * ECOG PS 0-2 (CP CML) * ECOG PS 0-3 (AD CML and Ph+ ALL) * Adequate hepatic and renal function Exclusion Criteria: * Pregnant or breastfeeding females * History of significant cardiac disease * History of significant bleeding disorder (not CML)

Locations (20)

Local Institution

Budapest, Hungary

Local Institution

Bologna, Italy

Outcomes

Primary Outcomes

Incidence and severity of drug-related adverse events.

Secondary Outcomes

Chronic Phase CML: Cytogenetic and Hematologic Response

Advanced Phase CML and Philadelphia positive ALL: Hematologic Response

Time to and duration of Cytogenetic and Hematologic Response

Data from ClinicalTrials.gov

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