Bosutinib in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase After Frontline TKI Failure

NCT02906696

Last updated date
Study Location
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Blasts Under 15 Percent of Bone Marrow Nucleated Cells, Blasts Under 15 Percent of Peripheral Blood White Cells, Blasts Under 30 Percent of Bone Marrow Nucleated Cells, Blasts Under 30 Percent of Peripheral Blood White Cells, BCR-ABL1
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with chronic myeloid leukemia (CML) in chronic phase who have resistance and/or intolerance to frontline TKI therapy; resistance is defined as lack (lack defined as response not achieved or lost by the given dates mentioned hereafter) of CHR (complete hematologic response) within 3 months, lack of major cytogenetic response (MCyR) within 6 months, and lack of CCyR within 12 months of therapy with frontline TKIs; in addition, loss of MCyR, CCyR or MMR at any time during the course of therapy is also considered resistance to therapy; intolerance is defined as persistent or severe toxicity that is unacceptable to the patient

- Chronic phase disease is defined as:

- < 15% blasts in peripheral blood and bone marrow;

- < 30% blasts plus promyelocytes in peripheral blood and bone marrow;

- < 20% basophils in peripheral blood;

- >= 100 x 10^9/L platelets (>= 100,000/mm^3);

- No evidence of extramedullary disease except hepatosplenomegaly; and

- No prior diagnosis of accelerated phase (AP) or blastic phase-chronic myeloid leukemia (BP-CML); patients with clonal evolution but no other criteria for accelerated phase are eligible

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Creatinine less than or equal to 2.0 mg/dl

- Bilirubin less than or equal to 2.0 mg/dl

- Alanine aminotransferase (ALT) less than or equal to 3 times institutional upper limit of normal

- Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use one of the following effective contraception methods during the study and for 30 days following the last dose of study drug; effective methods of birth control include:

- Birth control pills, shots or implants (placed under the skin by a health care provider) or patches (placed on the skin);

- Intrauterine devices (IUDs);

- Condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy

- Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug

- Patients or their legally authorized representative must provide written informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Women who are pregnant or lactating


- Known to be human immunodeficiency virus (HIV)+


- Active and uncontrolled disease/infection that in the opinion of the treating
physician and principal investigator may affect the ability to participate in the
trial or put the patient at unduly high risk


- Unable or unwilling to sign the informed consent document


- Received no other investigational therapy within the past 14 days


- Presence of T315I mutation by ABL1 sequencing


- Patient is currently in complete cytogenetic remission (CCyR)

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Blasts Under 15 Percent of Bone Marrow Nucleated Cells, Blasts Under 15 Percent of Peripheral Blood White Cells, Blasts Under 30 Percent of Bone Marrow Nucleated Cells, Blasts Under 30 Percent of Peripheral Blood White Cells, BCR-ABL1Bosutinib in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase After Frontline TKI Failure
NCT02906696
  1. Houston, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Bosutinib in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase After Frontline TKI Failure
Official Title  ICMJE An Open-Label Phase II Dose Optimization Study of Bosutinib at a Starting Dose of 300 Mg Daily for Adult Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase Post Frontline TKI Failure
Brief Summary This phase II trial studies how well bosutinib works in treating patients with chronic myeloid leukemia in chronic phase after frontline tyrosine kinase inhibitor (TKI) failure. Bosutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed Description

PRIMARY OBJECTIVES:

I. To assess the response rate within 24 weeks in patients in chronic phase receiving bosutinib with the starting dose of 300 mg per day, with potential escalation to 400 mg, 500 mg and 600 mg per day.

SECONDARY OBJECTIVES:

I. Safety of dosing schedule. II. Frequency of treatment interruptions and dose reductions. III. Determine the rate of BCR-ABL/ABL < 10% at 3 months and < 1% at 6 months on the international scale and the rate of complete cytogenetic response (CCyR) at 6 months after the start of treatment.

IV. Determine the cumulative rate of CCyR. V. Determine the rate of major molecular response, molecular response (MR)4, MR4.5 and complete molecular response.

VI. Determine long-term outcomes, including progression-free survival, event-free survival, and overall survival.

VIII. Investigate the correlation between ABL kinase domain mutations, if present at the time of enrollment, with outcome.

IX. Determine the rate of development and type of ABL kinase domain mutations during therapy with bosutinib.

OUTLINE:

Patients receive bosutinib orally (PO) daily on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 12 weeks for up to 2 years, every 24 weeks for 2 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Blasts Under 15 Percent of Bone Marrow Nucleated Cells
  • Blasts Under 15 Percent of Peripheral Blood White Cells
  • Blasts Under 30 Percent of Bone Marrow Nucleated Cells
  • Blasts Under 30 Percent of Peripheral Blood White Cells
  • Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Intervention  ICMJE
  • Drug: Bosutinib
    Given PO
    Other Names:
    • Bosulif
    • SKI 606
    • SKI-606
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Study Arms  ICMJE Experimental: Treatment (bosutinib)
Patients receive bosutinib PO daily on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: Bosutinib
  • Other: Laboratory Biomarker Analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 8, 2020)
8
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2016)
42
Actual Study Completion Date  ICMJE August 8, 2019
Actual Primary Completion Date August 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with chronic myeloid leukemia (CML) in chronic phase who have resistance and/or intolerance to frontline TKI therapy; resistance is defined as lack (lack defined as response not achieved or lost by the given dates mentioned hereafter) of CHR (complete hematologic response) within 3 months, lack of major cytogenetic response (MCyR) within 6 months, and lack of CCyR within 12 months of therapy with frontline TKIs; in addition, loss of MCyR, CCyR or MMR at any time during the course of therapy is also considered resistance to therapy; intolerance is defined as persistent or severe toxicity that is unacceptable to the patient
  • Chronic phase disease is defined as:

    • < 15% blasts in peripheral blood and bone marrow;
    • < 30% blasts plus promyelocytes in peripheral blood and bone marrow;
    • < 20% basophils in peripheral blood;
    • >= 100 x 10^9/L platelets (>= 100,000/mm^3);
    • No evidence of extramedullary disease except hepatosplenomegaly; and
    • No prior diagnosis of accelerated phase (AP) or blastic phase-chronic myeloid leukemia (BP-CML); patients with clonal evolution but no other criteria for accelerated phase are eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Creatinine less than or equal to 2.0 mg/dl
  • Bilirubin less than or equal to 2.0 mg/dl
  • Alanine aminotransferase (ALT) less than or equal to 3 times institutional upper limit of normal
  • Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use one of the following effective contraception methods during the study and for 30 days following the last dose of study drug; effective methods of birth control include:

    • Birth control pills, shots or implants (placed under the skin by a health care provider) or patches (placed on the skin);
    • Intrauterine devices (IUDs);
    • Condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
  • Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
  • Patients or their legally authorized representative must provide written informed consent

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Known to be human immunodeficiency virus (HIV)+
  • Active and uncontrolled disease/infection that in the opinion of the treating physician and principal investigator may affect the ability to participate in the trial or put the patient at unduly high risk
  • Unable or unwilling to sign the informed consent document
  • Received no other investigational therapy within the past 14 days
  • Presence of T315I mutation by ABL1 sequencing
  • Patient is currently in complete cytogenetic remission (CCyR)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02906696
Other Study ID Numbers  ICMJE 2016-0081
NCI-2016-01954 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0081 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Pfizer
Investigators  ICMJE
Principal Investigator:Philip A ThompsonM.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP