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Trial record 1 of 1 for:    BOS-IIG-01
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CML Treated With Bosutinib After Relapse (BOSTRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02445742
Recruitment Status : Active, not recruiting
First Posted : May 15, 2015
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation

Brief Summary:
Prospective, open label, multicenter, phase II study evaluating correlation of SNPs with efficacy and toxicity in patients treated with Bosutinib. A total of 50 patients with previously treated Ph+ chronic phase CML will be included in the study

Condition or disease Intervention/treatment Phase
Chronic Myeloblastic Leukaemia Drug: Bosutinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Nucleotide Polymorphism Association With Response and Toxic Effects in Patients With Ph+ CP-CML Treated With Bosutinib After Relapse to Previous Treatment
Actual Study Start Date : May 2015
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Bosutinib

Arm Intervention/treatment
Experimental: Bosutinib
500 mg/day of Bosutinib during the study until disease progression, unacceptable toxicity, or withdrawal of consent occurs
Drug: Bosutinib
500 mg/day of Bosutinib during the study until disease progression, unacceptable toxicity, or withdrawal of consent occurs
Other Name: Bostro




Primary Outcome Measures :
  1. Safety measured as adverse event gradation [ Time Frame: 2 years ]
    Safety measured as graded adverse events described on common terminology criteria for adverse events


Secondary Outcome Measures :
  1. Efficacy measured as response rate [ Time Frame: 2 years ]
    Eficaccy measured as response rate to treatment



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Signed and dated informed consent form.
  • Patients with chronic Ph + CML who presented a non-optimal response at 3 months prior to ITK treatment (imatinib, nilotinib, dasatinib). It is defined as a non-optimal response:

BCR-ABL> 10% per qRT-PCR (IS) at 3 months of initiation of treatment. BCR / ABL ≥ 1% per qRT-PCR (IS) at 6 months of initiation of treatment. BCR / ABL> 0.1% qRT-PCR (IS) at 12 months of initiation of treatment. BCR-ABL1> 0.1% qRT-PCR (IS) at any time after 12 months of treatment initiation.

  • ECOG Performance Status of 0 or 1.
  • Recovery at Grade 0-1, or at the baseline value of any pretreatment toxicity, except for alopecia. Cases with significant toxicity will be analyzed individually by the study coordinators
  • Able to take daily oral capsules
  • Adequate bone marrow function:

    1. Absolute neutrophil count > 1000/mm3 (>1000 x109/L)
    2. Platelets ≥ 100,000/mm3 (>100 x109/L)
    3. absent any platelet transfusions during the preceding 14 days.
  • Adequate hepatic, and renal function:

    • AST/ALT ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN if attributable to liver involvement of leukemia
    • Total bilirubin ≤ 1.5 × ULN
    • Creatinine ≤ 1.5 × ULN
  • Age > 18 years
  • Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control (oral contraceptives, intrauterine devices, or barrier methods used with a spermicide) for the duration of the study and for 30 days after the last dose of Bosutinib.

Exclusion Criteria

  • Subjects with Philadelphia chromosome and bcr-abl negative CML.
  • Overt leptomeningeal leukemia. Subjects must be free of CNS involvement for a minimum of 2 months. Subjects with symptoms of CNS involvement must have a diagnostic lumbar puncture prior to study enrollment.
  • Subjects with extramedullary disease only.
  • Prior stem cell transplantation.
  • Major surgery within 14 days or radiotherapy within 7 days before the first dose of Bosutinib (recovery from any previous surgery should be complete before day 1)
  • A history of a clinically significant ventricular arrhythmia, congenital or acquired prolonged QT interval, a baseline QTcF > 0.47 sec (average of triplicate readings) or unexplained syncope, uncontrolled or symptomatic congestive heart failure (CHF) within 3 months, or myocardial infarction (MI) within 6 months.
  • Concomitant use of or need for medications known to prolong the QT interval
  • Uncorrected hypomagnesemia or hypokalemia due to potential effects on the QT interval
  • Recent (within 30 days of study entry) or ongoing clinically significant gastrointestinal disorder (e.g., malabsorption, short bowel syndrome, bleeding, or grade >1 diarrhea, nausea or emesis lasting more than 2 days, despite adequate medical therapy)
  • Pregnant or breastfeeding women
  • Evidence of serious active infection, or significant medical or psychiatric illness
  • Known seropositivity to HIV, or current acute or chronic Hepatitis B or Hepatitis C (antigen positive), cirrhosis, hypokalemia (any grade), or clinically significant abnormal laboratory finding that would, in the investigator's judgment, make the subject inappropriate for this study.

Information from the National Library of Medicine

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): NCT02445742


Locations
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Spain
C. H. U. de Gran Canaria Dr. Negrín
Gran Canaria, Spain
C. H. Gregorio Marañón
Madrid, Spain
C. U. La Paz - H. U. La Paz
Madrid, Spain
H. Ramón y Cajal
Madrid, Spain
H. U. de la Princesa
Madrid, Spain
H. U. Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
C. H. Regional de Málaga , H. General
Málaga, Spain
H. U. Son Espases
Palma de Mallorca, Spain
C. Asistencial U. de Salamanca
Salamanca, Spain
C. H. U. de Santiago
Santiago de Compostela, Spain
H. Virgen de la Salud
Toledo, Spain
Clínica Quirón Zaragoza S.A.
Zaragoza, Spain
Sponsors and Collaborators
PETHEMA Foundation
Investigators
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Study Chair: Luis Felipe Casado, Dr PETHEMA Foundation

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Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT02445742     History of Changes
Other Study ID Numbers: BOS-IIG-01
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

Keywords provided by PETHEMA Foundation:
Chronic Myeloblastic Leukaemia

Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms