Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007133

Trial Description

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Title

A Multicenter Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase (CP) Chronic Myelogenous Leukemia (CML)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

The study will be open for enrollment until the planned number of approximately 500
Philadelphia Chromosome Positive (Ph+) patients have been randomized (approximately 250 Ph+
patients in each treatment arm; a total of approximately 530 Ph+ and Ph- patients). All
patients will be treated and/or followed for approximately 5 years (240 weeks) after
randomization until the study has closed. Patients who discontinue study therapy early due
to disease progression or intolerance to study medication will continue to be followed
yearly for survival for up to approximately 5 years (240 weeks) after randomization.

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Organizational Data

  •   DRKS00007133
  •   2014/12/19
  •   2014/05/01
  •   no
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Secondary IDs

  •   NCT02130557  (ClinicalTrials.gov)
  •   AV001  (Avillion Development 1 Limited)
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Health Condition or Problem studied

  •   Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
  •   C92.1 -  Chronic myeloid leukaemia [CML], BCR/ABL-positive
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Interventions/Observational Groups

  •   Drug: Bosutinib
  •   Drug: Imatinib
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Compare proportion of participants with Major Molecular Response (MMR) at 12 Months in the bosutinib arm with that of the imatinib arm; time frame: 12 Months; MMR is defined as <0.1%Bcr-Abl1 on the International Scale (IS) by Real Time Quantitative Polymerase Chain Reaction (RT-PCR)

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Secondary Outcome

- Compare proportion of participants with MMR at 18 Months in the bosutinib treatment group with the imatinib treatment group; time frame: 18 Months
- To determine the duration of MMR in the bosutinib treatment group with the imatinib treatment group; time frame: 5 Years; Duration of MMR is measured only for participants who initially respond to study medication.
- To determine the proportion of participants with Complete Cytogenetic Response (CCyR) by 12 Months in both treatment groups; time frame: 12 Months; CCyR is defined as absence of detectable Ph chromosomes in bone marrow aspirate
- To determine the duration of CCyR in both treatment groups; time frame: 5 Years; Duration of response is measured only for participants who initially respond to study medication.

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Countries of Recruitment

  •   United States
  •   Belgium
  •   Canada
  •   Czech Republic
  •   Denmark
  •   France
  •   Germany
  •   Hungary
  •   Italy
  •   Korea, Republic of
  •   Netherlands
  •   Norway
  •   Poland
  •   Singapore
  •   Slovakia
  •   Spain
  •   Sweden
  •   Ukraine
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2014/06/30
  •   530
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Molecular diagnosis of CP CML of ≤ 6 months (from initial diagnosis).

2. Adequate hepatic, renal and pancreatic function.

3. Age ≥ 18 years.

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Exclusion Criteria

1. Any prior medical treatment for CML, including tyrosine kinase inhibitors (TKIs),
with the exception of hydroxyurea and/or anagrelide treatment, which are permitted
for up to 6 months prior to study entry (signature of ICF) if suitably approved for
use in the subject's region.

2. Any past or current Central Nervous System (CNS) involvement, including
leptomeningeal leukemia.

3. Extramedullary disease only.

4. Major surgery or radiotherapy within 14 days of randomization.

5. History of clinically significant or uncontrolled cardiac disease.

6. Known seropositivity to human immunodeficiency virus (HIV), current acute or chronic
hepatitis B (hepatitis B surface-antigen positive), hepatitis C, cirrhosis or
evidence of decompensated liver disease. Patients with resolved Hepatitis B can be
included.

7. Recent or ongoing clinically significant GI disorder, e.g. Crohn's Disease,
Ulcerative Colitis, or prior total or partial gastrectomy.

8. History of another malignancy within 5 years with the exception of basal cell
carcinoma or cervical carcinoma in situ or stage 1 or 2 cancer that is considered
adequately treated and currently in complete remission for at least l2 months.

9. Current, or recent (within 30 days, or 5 half-lives of investigational product)
participation in other clinical trials of investigational agents and/or containing
interventional procedures deemed contrary to the objectives and conduct of this
trial.

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Addresses

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    • Avillion Development 1 Limited
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    • Dr. Laurence Reilly, MBChB LLM 
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    • Dr. Laurence Reilly, MBChB LLM 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2015/05/04
* This entry means the parameter is not applicable or has not been set.