Chronic Myeloblastic LeukaemiaPhase 2BOSTRONCT02445742
CML Treated With Bosutinib After Relapse
A Phase 2 study testing Bosutinib in people with Chronic Myeloblastic Leukaemia, run by PETHEMA Foundation at 13 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloblastic Leukaemia
- What is being tested?
- Bosutinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 13 sitesSpain
- Study dates
- May 2015to 27 Jun 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
C. H. U. de Gran Canaria Dr. Negrín
Gran Canaria
C. H. Gregorio Marañón
Madrid
C. U. La Paz - H. U. La Paz
Madrid
H. Ramón y Cajal
Madrid
H. U. de la Princesa
Madrid
H. U. Fundación Jiménez Díaz
Madrid
Hospital Universitario 12 de Octubre
Madrid
C. H. Regional de Málaga , H. General
Málaga
H. U. Son Espases
Palma de Mallorca
C. Asistencial U. de Salamanca
Salamanca
C. H. U. de Santiago
Santiago de Compostela
H. Virgen de la Salud
Toledo
Clínica Quirón Zaragoza S.A.
Zaragoza
About this study
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
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
- Being tested
- Bosutinib
- Keywords
- Chronic Myeloblastic Leukaemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosutinibDrug
Also called Bostro
500 mg/day of Bosutinib during the study until disease progression, unacceptable toxicity, or withdrawal of consent occurs
| Study group | Role | What they receive |
|---|---|---|
| Bosutinib | Experimental | 500 mg/day of Bosutinib during the study until disease progression, unacceptable toxicity, or withdrawal of consent occurs Receives: Drug: Bosutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured as adverse event gradation
Safety measured as graded adverse events described on common terminology criteria for adverse events
Measured: 2 years
Secondary outcomes (1)
Efficacy measured as response rate
Eficaccy measured as response rate to treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2018
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloblastic LeukaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis Felipe Casado, Dr, Study chair, PETHEMA Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445742
- Sponsor's protocol ID
- BOS-IIG-01
- Acronym
- BOSTRO
- Status last verified
- Apr 2020
- First submitted
- 6 May 2015
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02445742
- Acronym / sponsor ID
- BOSTRO / BOS-IIG-01
- Conditions
- Chronic Myeloblastic Leukaemia
- Keywords
- Chronic Myeloblastic Leukaemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bosutinib | Experimental | Drug: Bosutinib500 mg/day of Bosutinib during the study until disease progression, unacceptable toxicity, or withdrawal of consent occurs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BosutinibAlso: Bostro500 mg/day of Bosutinib during the study until disease progression, unacceptable toxicity, or withdrawal of consent occurs | Drug | Bosutinib |
Primary outcome
Safety measured as adverse event gradation
Time frame: 2 years
Safety measured as graded adverse events described on common terminology criteria for adverse events
1 secondary outcome
Efficacy measured as response rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Felipe Casado, Dr study chair
PETHEMA Foundation
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bosutinib in people with Chronic Myeloblastic Leukaemia, run by PETHEMA Foundation at 13 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured as adverse event gradation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.