Description:
The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to
the European Medicines Agency in providing additional safety and efficacy data in
approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with
high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase
patients in the fourth or later line treatment setting (i.e., after treatment with at least 3
other Tyrosine Kinase Inhibitors).
Title
- Brief Title: Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
- Official Title: A PHASE 4 SAFETY AND EFFICACY STUDY OF BOSUTINIB (BOSULIF (REGISTERED)) IN PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA PREVIOUSLY TREATED WITH ONE OR MORE TYROSINE KINASE INHIBITORS
Clinical Trial IDs
- ORG STUDY ID:
B1871039
- SECONDARY ID:
2013-003250-25
- SECONDARY ID:
BYOND
- NCT ID:
NCT02228382
Conditions
- Previously Treated PH + CML
Interventions
| Drug | Synonyms | Arms |
|---|
| Bosutinib | BOSULIF | Bosutinib |
Purpose
The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to
the European Medicines Agency in providing additional safety and efficacy data in
approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with
high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase
patients in the fourth or later line treatment setting (i.e., after treatment with at least 3
other Tyrosine Kinase Inhibitors).
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Bosutinib | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- Confirmed Philadelphia Chromosome positive Chronic Myeloid Leukemia or Confirmed
BCR-ABL1 (Abelson-break point cluster) Positive if Philadelphia Chromosome negative
Chronic Myeloid Leukemia (from initial diagnosis).
- Prior treatment with 1 or more tyrosine kinase inhibitor drugs (imatinib, dasatinib
and/or nilotinib) for Philadelphia Chromosome positive Chronic Myeloid Leukemia (CML).
- Any Chronic Myeloid Leukemia disease phase, as long as the patient is unable to
receive treatment with imatinib, dasatinib and/or nilotinib for any reason.
Exclusion Criteria:
- Participation in any other clinical studies involving investigational drug(s) within
14 days or within 3 half-lives of drug levels in blood (whichever is longer) prior to
the first dose of bosutinib.
- Prior treatment with bosutinib.
- Prior treatment with ponatinib.
- Known T315I or V299L mutation.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Percentage of Participants with Major Cytogenetic Response (MCyR) by Week 52 in Chronic Phase Second-line Population and Chronic Phase Third-line Population of Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients. |
| Time Frame: | Week 52 |
| Safety Issue: | |
| Description: | Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive cells in metaphase from Bone Marrow sample. |
Secondary Outcome Measures
| Measure: | Estimate cumulative probability of Percentage of Participants with Major Cytogenetic Response in Chronic Phase and Advanced Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia patient populations. |
| Time Frame: | Week 52 |
| Safety Issue: | |
| Description: | Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive cells in metaphase from Bone Marrow sample. |
| Measure: | Estimate cumulative probability of Percentage of Participants with Overall Hematologic Response in the Accelerated Phase and Blast Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia patient population by number of lines of prior therapy. |
| Time Frame: | Week 52 |
| Safety Issue: | |
| Description: | OHR includes Complete Hematological Response (CHR) or return to chronic phase (RCP). |
| Measure: | Characterize distribution of best response (molecular, cytogenetic, or hematologic) in the Chronic Phase, Accelerated Phase and Blast Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia patient populations. |
| Time Frame: | Week 52 |
| Safety Issue: | |
| Description: | |
| Measure: | Estimating probability of Percentage of Participants with Major Cytogenetic Response at 3, 6, 12, 18, and 24 months in the Chronic Phase, Accelerated Phase and Blast Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia patient populations. |
| Time Frame: | Month 3, 6, 12, 18, and 24 |
| Safety Issue: | |
| Description: | |
| Measure: | Estimating the probability of confirmed Overall Hematologic Response at 3, 6, 9, 12, 18, and 24 months in the Accelerated Phase and Blast Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia patient populations. |
| Time Frame: | Month 3, 6, 9, 12, 18, and 24 |
| Safety Issue: | |
| Description: | |
| Measure: | Estimating the probability of cumulative confirmed Complete Hematologic Response in the Chronic Phase, Accelerated Phase and Blast Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia patient populations. |
| Time Frame: | Week 52 |
| Safety Issue: | |
| Description: | |
| Measure: | Estimating the probability of cumulative major molecular response in the Chronic Phase, Accelerated Phase and Blast Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia patient populations. |
| Time Frame: | Week 52 |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 4 |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | Pfizer |
Trial Keywords
- Bosutinib
- Chronic Myeloid Leukemia
- CML
- Leukemia
- Myelogenous
- Chronic
- BC-ABL Positive
Last Updated
July 27, 2021
