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Tyrosine Kinase Inhibitor

Bosutinib for Chronic Myelogenous Leukemia

Verified Trial
Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Molecular diagnosis of CP CML of ≤ 6 months (from initial diagnosis).
Age ≥ 18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 60
Awards & highlights

Study Summary

Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

Eligible Conditions
  • Chronic Myelogenous Leukemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Major Molecular Response (MMR) at Month 12
Secondary outcome measures
Cumulative Incidence of Event Free Survival (EFS) Events
Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 48
Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 48
+3 more
Other outcome measures
Number of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Version 4.03
+6 more

Side effects data

From 2020 Phase 3 trial • 536 Patients • NCT02130557
75%
Diarrhoea
37%
Nausea
36%
Thrombocytopenia
34%
Alanine aminotransferase increased
26%
Aspartate aminotransferase increased
23%
Abdominal pain
23%
Rash
22%
Headache
22%
Anaemia
21%
Lipase increased
21%
Vomiting
21%
Fatigue
18%
Arthralgia
16%
Pyrexia
13%
Constipation
13%
Nasopharyngitis
13%
Asthenia
13%
Upper respiratory tract infection
12%
Back pain
12%
Neutropenia
11%
Pruritus
11%
Dyspnoea
11%
Decreased appetite
11%
Cough
10%
Dyspepsia
10%
Urinary tract infection
10%
Pain in extremity
10%
Abdominal pain upper
10%
Hypertension
9%
Influenza
9%
Amylase increased
9%
Dizziness
7%
Oedema peripheral
7%
Insomnia
7%
Dry skin
7%
Bronchitis
7%
Blood creatinine increased
7%
Leukopenia
6%
Influenza like illness
6%
Blood alkaline phosphatase increased
6%
Alopecia
6%
Blood bilirubin increased
6%
Oropharyngeal pain
6%
Sinusitis
6%
Anxiety
6%
Lymphopenia
5%
Toothache
5%
Abdominal distension
5%
Rash maculo-papular
5%
Myalgia
5%
Blood creatine phosphokinase increased
4%
Gastroenteritis
4%
Muscle spasms
3%
Face oedema
3%
Pneumonia
3%
Depression
3%
Gastrooesophageal reflux disease
3%
Bone pain
3%
Hypophosphataemia
3%
Weight increased
2%
Night sweats
2%
Hypokalaemia
2%
Vision blurred
1%
Coronary artery disease
1%
Cardiac failure acute
1%
Myocardial ischaemia
1%
Hypertensive crisis
1%
Pleural effusion
1%
Pericarditis
1%
Cholecystitis acute
1%
Cellulitis
1%
Femoral neck fracture
1%
Atrial fibrillation
1%
Hepatitis
1%
Hepatotoxicity
1%
Pregnancy of partner
1%
Unintended pregnancy
1%
Chronic kidney disease
1%
Acute kidney injury
1%
Respiratory failure
1%
Musculoskeletal chest pain
1%
Rectal cancer
1%
Haematuria
1%
Periorbital oedema
1%
Eyelid oedema
1%
Conjunctival haemorrhage
1%
Dry eye
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bosutinib
Imatinib

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BosutinibExperimental Treatment1 Intervention
Bosutinib, 400 mg, oral administration once a day
Group II: ImatinibActive Control1 Intervention
Imatinib, 400 mg, oral administration once a day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bosutinib
FDA approved

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,338 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,506 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
2014. "A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02130557.
~50 spots leftby Apr 2025
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