Rollover Study of BMS-354825 in Patients With CML and Ph+ALL

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia

Treatments

Drug: dasatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01030718
CA180-036

Details and patient eligibility

About

To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) who are resistant or intolerant to treatment and will continue study drug after completing the previous Phase I/II study (CA180031/NCT00337454)

Enrollment

54 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects who were eligible and completed the previous Phase I and II study (CA180031/NCT00337454) and for whom the principal investigator has deemed that continuation of study drug is in the best interest of the subject

Exclusion criteria

  • Women who are pregnant or breastfeeding
  • Subjects who are eligible and willing to undergo transplantation at pre-study
  • Non-hematologic intolerance to Dasatinib (BMS-354825) in the previous Phase I and II study (CA180031/NCT00337454)

Trial design

54 participants in 3 patient groups

dasatinib (CML-CP)
Experimental group
Description:
CML - Chronic Phase
Treatment:
Drug: dasatinib
dasatinib (CML-AP/BP)
Experimental group
Description:
CML - Accelerated Phase and Blast Phase
Treatment:
Drug: dasatinib
dasatinib (Ph+ ALL)
Experimental group
Description:
Ph+ Acute Lymphoblastic Leukemia
Treatment:
Drug: dasatinib

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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