Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

NCT ID: NCT03128411

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-15
• Study Completion Date: 2021-03-04

Brief Summary

Phase 2, single-arm, open-label trial. Patients will receive bosutinib for the duration of the study.

Detailed Description

The study will be open for enrollment until the planned number of approximately 60 Philadelphia Chromosome Positive (Ph+) patients have been registered. All patients will be treated and/or followed for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination.

Conditions

Leukemia, Chronic Myelogenous

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bosutinib

Bosutinib monotherapy; All patients will receive bosutinib at a starting dose of 400 mg QD. The dose of bosutinib may be escalated (up to a maximum of 600 mg QD) for unsatisfactory response or reduced for toxicity.

Group Type: EXPERIMENTAL

Bosutinib

Intervention Type: DRUG

All patients will receive bosutinib at a starting dose of 400 mg QD.

Interventions

Bosutinib

All patients will receive bosutinib at a starting dose of 400 mg QD.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of CP CML of ≤6 months (from initial diagnosis); Diagnosis of CP CML with molecular confirmation by detection of BCR-ABL rearrangement at screening (cytogenetic assessment for Ph is not required for enrollment; however, patients with known Ph- CML prior to registration are not eligible for this study)
• Age ≥20 years
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Adequate Liver and Renal Function

Exclusion Criteria

• Any prior medical treatment for CML, including TKIs, with the exception of hydroxyurea treatment, which is permitted for up to 6 months prior to registration
• Any past or current CNS involvement, including leptomeningeal leukemia
• Extramedullary disease only
• Major surgery or radiotherapy within 14 days prior to registration
• History of clinically significant or uncontrolled cardiac disease
• Patients with active, uncontrolled bacterial, fungal, or viral infection
• Recent or ongoing clinically significant GI disorder
• History of another malignancy within 5 years prior to registration
• Uncontrolled hypomagnesemia or uncorrected hypokalemia due to potential effects on the QT interval
• Known prior or suspected severe hypersensitivity to study drugs or any component in their formulations
• Participation in other studies involving investigational drug(s) within 30 days or 5 half-lives of investigational product, whichever is longer, prior to registration and/or during study participation
• Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results
• Investigational site staff members directly involved in the conduct of the study and their family members, or Pfizer employees, including their family members, directly involved in the conduct of the study

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Toyohashi Municipal Hospital

Toyohashi, Aichi-ken, Japan

Akita University Hospital

Akita, Akita, Japan

Japanese Red Cross Narita Hospital

Narita, Chiba, Japan

Ehime University Hospital

Toon-shi, Ehime, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, Japan

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, Osaka, Japan

Osaka City University Hospital

Osaka, Osaka, Japan

Kindai University Hospital

Ōsaka-sayama, Osaka, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Bunkyo-ku, Tokyo, Japan

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, Japan

National Hospital Organization Disaster Medical Center

Tachikawa, Tokyo, Japan

Yamagata University Hospital

Yamagata, Yamagata, Japan

Chiba University Hospital

Chiba, , Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Saga University Hospital

Saga, , Japan

Nippon Medical School Hospital

Tokyo, , Japan

Countries

Japan

References

Garrett M, Knight B, Cortes JE, Deininger MW. Population modeling of bosutinib exposure-response in patients with newly diagnosed chronic phase chronic myeloid leukemia. Cancer Med. 2023 Sep;12(17):17981-17992. doi: 10.1002/cam4.6439. Epub 2023 Aug 8.

Reference Type: DERIVED

PMID: 37553873 (View on PubMed)

Ono T, Hino M, Matsumura I, Fujisawa S, Ishizawa K, Sakaida E, Sekiguchi N, Ono C, Aizawa M, Tanetsugu Y, Koide Y, Takahashi N. Bosutinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia: final 3-year follow-up results of a phase 2 study. Int J Hematol. 2022 Dec;116(6):871-882. doi: 10.1007/s12185-022-03435-4. Epub 2022 Aug 13.

Reference Type: DERIVED

PMID: 35963986 (View on PubMed)

Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, Garcia-Gutierrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brummendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.

Reference Type: DERIVED

PMID: 35235189 (View on PubMed)

Hino M, Matsumura I, Fujisawa S, Ishizawa K, Ono T, Sakaida E, Sekiguchi N, Tanetsugu Y, Fukuhara K, Ohkura M, Koide Y, Takahashi N. Phase 2 study of bosutinib in Japanese patients with newly diagnosed chronic phase chronic myeloid leukemia. Int J Hematol. 2020 Jul;112(1):24-32. doi: 10.1007/s12185-020-02878-x. Epub 2020 Apr 11.

Reference Type: DERIVED

PMID: 32279228 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B1871048

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Other Identifiers

B1871048

Identifier Type: -

Identifier Source: org_study_id