Clinical trial NCT01030718: Rollover Study of BMS-354825 in Patients With CML and Ph+ALL
Official title: A Study to Document the Long-Term Safety and Efficacy of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Previous Treatment and Have Completed the Previous Phase I/II Protocol (CA180-031/NCT00337454)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Myelogenous Leukemia
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-12-11
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation
timeFrame: baseline; every 4 weeks (if on study < 6 months, including CA180-031(NCT00337454); every 12 weeks (if on study >=6 months and <=2 years); every 24 weeks (if on study >2 years); at discontinuation
Secondary outcomes:
measure: Participants With Chronic Phase CML (CML-CP): Percentage of Participants With Cytogenetic Response
timeFrame: At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)
measure: Participants With CML-Accelerated or Blast Phase (AP/BP): Percentage of Participants With Cytogenetic Response
timeFrame: At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter
measure: Participants With Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL): Percentage of Participants With Cytogenetic Response
timeFrame: At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter
measure: Participants With CML-CP: Time to Complete Cytogenetic Response (CCyR)
timeFrame: At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454),
measure: Participants With CML-AP/BP and Ph+ ALL: Time to Complete Cytogenetic Response (CCyR)
timeFrame: At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter
measure: Participants With CML-CP: Duration of Complete Cytogenetic Response (CCyR)
timeFrame: At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)
measure: Participants With CML-AP/BP and Ph+ALL: Duration of Complete Cytogenetic Response (CCyR)
timeFrame: At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter
measure: Participants With CML-CP: Time to Major Cytogenetic Response (MCyR)
timeFrame: At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)
measure: Participants With CML-AP/BP and Ph+ALL: Time to Major Cytogenetic Response (MCyR)
timeFrame: At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter
measure: Participants With CML-CP: Duration of Major Cytogenetic Response (MCyR)
timeFrame: At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)
measure: Participants With CML-AP/BP and Ph+ ALL: Duration of Major Cytogenetic Response (MCyR)
timeFrame: At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter
measure: Participants With CML-CP: Percentage of Participants With Complete Hematologic Response (CHR)
timeFrame: baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454), every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation
measure: Participants With CML-AP/BP: Percentage of Participants With Hematologic Response
timeFrame: baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation
measure: Participants With Ph+ ALL: Percentage of Participants With Hematologic Response
timeFrame: baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation
measure: Time to Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL
timeFrame: baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation
measure: Duration of Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL
timeFrame: baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation
measure: Time to Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL
timeFrame: baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation
measure: Duration of Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL
timeFrame: baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation
measure: Time to Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL
timeFrame: baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation
measure: Duration of Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL
timeFrame: baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation
measure: Participants With Detectable Mutations of RNA (mRNA) of BCR-ABL at Baseline and at Best Achievement
timeFrame: At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter, and at discontinuation
measure: Status of Point Mutations of BCR-ABL at Baseline (BL) and End of Study (EOS)
timeFrame: At baseline and discontinuation--the study period was extended until the launch of dasatinib in Japan, January 2009.
measure: Collection of Blood Samples for Pharmacokinetic Analysis of Dasatinib Twice Daily (BID) That Will Contribute to Population Pharmacokinetic Modeling
timeFrame: At any visit of later than Day 7, draw sample(s) at pretreatment trough (within 1 hour prior to dosing) or between 3 hours following treatment and prior to the next dose
Other outcomes:
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