CML Treated With Bosutinib After Relapse

NCT02445742 | Completed Phase 2 DMC

• 1 other identifier: BOS-IIG-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 13

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

Conditions

Chronic Myeloblastic Leukaemia

Keywords

Chronic Myeloblastic Leukaemia

Outcome Measures

Primary Outcomes (1)

• Safety measured as adverse event gradation

  Safety measured as graded adverse events described on common terminology criteria for adverse events

  2 years

Secondary Outcomes (1)

• Efficacy measured as response rate

  2 years

Study Arms (1)

Bosutinib

EXPERIMENTAL

500 mg/day of Bosutinib during the study until disease progression, unacceptable toxicity, or withdrawal of consent occurs

Drug: Bosutinib

Interventions

Bosutinib DRUG

500 mg/day of Bosutinib during the study until disease progression, unacceptable toxicity, or withdrawal of consent occurs

Also known as: Bostro

Bosutinib

Eligibility Criteria

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

You may qualify if:

• 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:
• Absolute neutrophil count \> 1000/mm3 (\>1000 x109/L)
• Platelets ≥ 100,000/mm3 (\>100 x109/L)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PETHEMA Foundation: lead

Study Sites (13)

C. H. U. de Gran Canaria Dr. Negrín

Gran Canaria, Spain

Location

C. H. Gregorio Marañón

Madrid, Spain

Location

C. U. La Paz - H. U. La Paz

Madrid, Spain

Location

H. Ramón y Cajal

Madrid, Spain

Location

H. U. de la Princesa

Madrid, Spain

Location

H. U. Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

C. H. Regional de Málaga , H. General

Málaga, Spain

Location

H. U. Son Espases

Palma de Mallorca, Spain

Location

C. Asistencial U. de Salamanca

Salamanca, Spain

Location

C. H. U. de Santiago

Santiago de Compostela, Spain

Location

H. Virgen de la Salud

Toledo, Spain

Location

Clínica Quirón Zaragoza S.A.

Zaragoza, Spain

Location

MeSH Terms

Interventions

bosutinib

Study Officials

• Luis Felipe Casado, Dr

  PETHEMA Foundation

  STUDY CHAIR

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: May 6, 2015
• First Posted: May 15, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: June 27, 2019
• Last Updated: April 29, 2020

Record last verified: 2020-04

Locations

ES (13)