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

NCT02906696 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: 2016-0081NCI-2016-01954P30CA016672
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Response is defined as follows: 1) For patients who do not currently have a partial cytogenetic response (PCyR), achievement of major cytogenetic response is considered a response. 2) For patients who are currently in PCyR, achievement of CCyR is considered a response. The Simon's optimal two-stage design will be used for interim futility monitoring. Will be estimated along with the 95% credible interval.

  Up to 6 months

Secondary Outcomes (8)

• Number of Participants With Treatment Interruptions and Dose Reductions

  Up to 2 years

• Rates of Major Molecular Response (MR), MR4, MR4.5 and Complete Molecular Response

  Up to 2 years

• Rates of BCR-ABL/ABL <10%

  At 3 months

• Rates of BCR-ABL/ABL < 1%

  At 6 months

• Overall Survival

  Up to 2 years

Study Arms (1)

Treatment (bosutinib)

EXPERIMENTAL

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.

Drug: Bosutinib; Other: Laboratory Biomarker Analysis

Interventions

Bosutinib DRUG

Given PO

Also known as: Bosulif, SKI 606, SKI-606

Treatment (bosutinib)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (bosutinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Pfizer: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

bosutinib

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Philip Thompson, MD/Assistant Professor
• Organization: The University of Texas MD Anderson Cancer Center

PAThompson2@mdanderson.org

713-792-7430

Study Officials

• Philip A Thompson

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2016
• First Posted: September 20, 2016
• Study Start: October 28, 2016
• Primary Completion: August 8, 2019
• Study Completion: August 8, 2019
• Last Updated: May 11, 2020
• Results First Posted: April 22, 2020

Record last verified: 2020-04

Locations

US (1)