A randomized open-label study of 400 mg versus 800 mg of Gleevec/Glivec (imatinib mesylate) in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpointsEstudio abierto, aleatorizado de Glivec (mesilato de imatinib) 400 mg frente a 800 mg en pacientes con leucemia mieloide crónica (LCM-FC), recien diagnosticada y no tratada previamente, utilizando variables moleculares
- Conditions
- ewly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP)
- Registration Number
- EUCTR2005-000657-29-ES
- Lead Sponsor
- ovartis Farmacéutica, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
1. Ability to provide written informed consent prior to participation to the study. 2. Male or female patients = 18 and = 75 years of age 3. Patients within 6 months of diagnosis (date of initial diagnosis is the date of first cytogenetic analysis) 4. Diagnosis of chronic myelogenous leukemia in chronic phase with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations and presence of Bcr-Abl 5. Documented chronic phase CML as defined by: • < 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 109/L (= 100,000 /mm3) platelets • No evidence of extramedullary leukemic involvement, with the exception of hepatospenomegaly 6. Adequate end organ function as defined by: • total bilirubin < 1.5 x ULN • SGOT and SGPT < 2.5 x UNL • creatinine < 1.5 x ULN 7. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before initiation of study drug
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Patients in late chronic phase, accelerated phase, or blastic phase are excluded 2. Patients who have received other investigational agents 3. Patients who received Gleevec/Glivec for any duration prior to study entry, with the exception of those patients successfully completing [CSTIA2107] study immediately prior to the participation in this study 4. Patient received any treatment for CML prior to study entry for longer than 1 month with the exception of hydroxyurea and/or anagrelide 5. Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention 6. Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (d) male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential). 7. Patient with a severe or uncontrolled medical condition (i.e., uncontrolled diabetes, chronic renal disease) 8. Patient previously received radiotherapy to = 25% of the bone marrow 9. Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery 10. Patients with an ECOG Performance Status Score = 3 11. Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x IULN, with the exception of patients on treatment with oral anticoagulants 12. Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required 13. Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent 14. Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method