Chronic Myeloblastic Leukaemia Clinical Trial
— BOSTROOfficial title:
Single Nucleotide Polymorphism Association With Response and Toxic Effects in Patients With Ph+ CP-CML Treated With Bosutinib After Relapse to Previous Treatment
| NCT number | NCT02445742 |
| Other study ID # | BOS-IIG-01 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | May 2015 |
| Est. completion date | June 27, 2019 |
| Verified date | April 2020 |
| Source | PETHEMA Foundation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | June 27, 2019 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| PETHEMA Foundation |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety measured as adverse event gradation | Safety measured as graded adverse events described on common terminology criteria for adverse events | 2 years | |
| Secondary | Efficacy measured as response rate | Eficaccy measured as response rate to treatment | 2 years |