Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
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ClinicalTrials.gov Identifier: NCT02228382 |
Recruitment Status :
Completed
First Posted : August 29, 2014
Last Update Posted : March 1, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Previously Treated PH + CML | Drug: Bosutinib | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 162 participants |
Allocation: | N/A |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 7, 2014 |
Actual Primary Completion Date : | October 13, 2020 |
Actual Study Completion Date : | October 13, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Bosutinib |
Drug: Bosutinib
100 mg and 500 mg tablets, once daily dosage up to 4 years duration
Other Name: BOSULIF |
- 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 ]Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive cells in metaphase from Bone Marrow sample.
- Percentage of Participants with Major Cytogenetic Response (MCyR) by Week 52 in Chronic Phase Fourth-line and later-line Population of Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients. [ Time Frame: Week 52 ]Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive cells in metaphase from Bone Marrow sample.
- Percentage of Participants with Overall Hematologic Response (OHR) by Week 52 in Advanced Leukemia Population patients. [ Time Frame: Week 52 ]OHR includes Complete Hematological Response (CHR) or return to chronic phase (RCP).
- 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 ]Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive cells in metaphase from Bone Marrow sample.
- 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 ]OHR includes Complete Hematological Response (CHR) or return to chronic phase (RCP).
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228382

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT02228382 |
Other Study ID Numbers: |
B1871039 2013-003250-25 ( EudraCT Number ) BYOND ( Other Identifier: Alias Study Number ) |
First Posted: | August 29, 2014 Key Record Dates |
Last Update Posted: | March 1, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
Bosutinib Chronic Myeloid Leukemia CML Leukemia |
Myelogenous Chronic BC-ABL Positive |
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome Neoplasms by Histologic Type Neoplasms |
Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Translocation, Genetic Chromosome Aberrations Pathologic Processes |