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

A Phase II Study of Dasatinib (BMS-354825) in Subjects With Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib

Status

Withdrawn

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00349518

Enrollment

Registered

2006-07-07

Start date

2006-12-31

Completion date

Unknown

Last updated

2016-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia

Keywords

Chronic and Advanced Phase CML and, Philadelphia Chromosome Positive ALL with imatinib intolerance or resistance

Brief summary

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.

Interventions

DRUGDasatinib

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Incidence and severity of drug-related adverse events.	—

Secondary

Measure	Time frame
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	—

Countries

Hungary, Italy, Netherlands, Poland, Russia, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026