A Randomized Open-label Study of 400 mg Versus 800 mg of Imatinib Mesylate in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Using Molecular Endpoints.

TerminadoFase 3ClinicalTrials.gov

ID: NCT00124748Tipo: INTERVENTIONALInicio: 1 de jun de 2005Fin estimado: 1 de nov de 2010

Traducción no disponible, mostrando original

Resumen

This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Patients within 6 months of diagnosis (date of initial diagnosis is the date of first cytogenetic analysis)
Diagnosis of chronic myelogenous leukemia (CML) in chronic phase with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations and presence of Breakpoint cluster region gene-abelson proto-oncogene (Bcr-Abl)
Documented chronic phase CML
Adequate end organ function as defined by:
total bilirubin \< 1.5 x Upper Limit of Normal (ULN)
Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) \< 2.5 x ULN
creatinine \< 1.5 x ULN

Criterios de exclusión

Patients in late chronic phase, accelerated phase, or blastic phase are excluded
Patients who have received other investigational agents
Patients who received Gleevec/Glivec for any duration prior to study entry, with the exception of those patients successfully completing \[CSTI571A2107 (NCT00428909)\] study immediately prior to the participation in this study
Patient received any treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
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).
Patient with a severe or uncontrolled medical condition (i.e., uncontrolled diabetes,chronic renal disease)
Patient previously received radiotherapy to ≥ 25% of the bone marrow
Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery
Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status Score ≥ 3
Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) \> 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants
Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required
Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment

Intervenciones

drug

Imatinib mesylate

Imatinib is packaged in bottles as 100mg and 400mg tablets

Ubicaciones

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

La Plata, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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