A Phase III Study of Dasatinib vs. Imatinib in patients with newlydiagnosed Chronic Phase CML.

• Conditions: ewly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia; MedDRA version: 14.0Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-005712-27-DE
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-20
• Last Update Posted: 18 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 518

Inclusion Criteria

1) Subjects able to provide written informed consent.
2) Patients must have Ph+ CML in CP which is defined by the presence of all of the
following criteria:
< 15% blasts in peripheral blood and bone marrow.
< 30% blasts plus promyelocytes in peripheral blood and bone marrow.
< 20% basophils in the peripheral blood.
= 100 x 10E9/L platelets.
No evidence of extramedullary leukemic involvement, with the exception of
hepatosplenomegaly. Ph+ or variants must be demonstrated by BM cytogenetics.
3) Previously untreated chronic CML.
4) Subjects must be enrolled in this study within approximately 3 months (90 days) after the date of first being diagnosed with CML, based on cytogenetic test results of bone marrow, demonstrating the presence of the Philadelphia chromosome or variants of the (9;22) translocation. Subjects are allowed to have secondary chromosomal abnormalities (i.e., clonal evolution) in addition to the Philadelphia chromosome and remain eligible.
5) ECOG Performance Status (PS) Score 0 - 2.
6) Adequate hepatic function defined as: total bilirubin = 2.0 times the institutional
ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
= 2.5 times the institutional upper limit of normal (ULN).
7) Adequate renal function defined as serum creatinine = 3 times the institutional ULN.
8) Men and women, ages 18 years and older.
9) Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for a period of at least
1 month (4 weeks) before and at least 1 month (4 weeks) after the last dose of
investigational product in such a manner that the risk of pregnancy is minimized.
10) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity
25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 466
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

1) WOCBP who are unwilling or unable to use an acceptable method to avoid
pregnancy for the entire study period and for at least one month (4 weeks) before and for at least 1 month (4 weeks) after the last dose of study medication.
2) WOCBP using a prohibited contraceptive method (Not applicable for this study).
3) Women who are pregnant or breastfeeding.
4) Women with a positive pregnancy test at enrollment or prior to administration of
study medication.
5) Men whose sexual partners are WOCBP, who are unwilling or unable to use an
acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) after completion of study medication.
6) A serious uncontrolled medical disorder or active infection that would impair the
ability of the subject to receive protocol therapy.
7) Known pleural effusion at baseline.
8) Uncontrolled or significant cardiovascular disease, including any of the following:
A myocardial infarction within 6 months; Uncontrolled angina within 3 months; Congestive heart failure within 3 months; Diagnosed or suspected congenital long QT syndrome; Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointe); Prolonged QTcF interval > 450 msec on pre-entry ECG
9) History of significant bleeding disorder unrelated to CML, including:
Diagnosed congenital bleeding disorders (e.g., von Willebrand’s disease);
Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor
VIII antibodies).
10) Prior chemotherapy for peripheral stem cell mobilization. (Prior collection of
unmobilized peripheral blood stem cells is permitted).
11) Prior or concurrent malignancy, except for the following:
adequately treated basal cell or squamous cell skin cancer; cervical carcinoma in situ;
adequately treated Stage I or II cancer from which the subject is currently in
complete remission; or any other cancer from which the subject has been disease-free for three years.
12) Evidence of digestive dysfunction that would prevent administration of study therapy by mouth.
13) Any prior treatment with interferon
14) Any prior treatment with dasatinib
15) Any prior treatment with imatinib
16) Any other prior systemic treatments, with anti-CML activity [except for anagrelide,
or hydroxyurea (HU)].
17) Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes. Subjects who have discontinued any of these medications must have a wash-out period of at least 5 days or at least 5 half-lives of the drug (whichever is greater) prior to the first dose of study therapy. Amiodarone must be discontinued for at least 14 days prior to randomization.
18) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified