An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib

CompletadoFase 2ClinicalTrials.gov

ID: NCT01593254Tipo: INTERVENTIONALInicio: 12 de sept de 2012Fin estimado: 12 de abr de 2022

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Chronic Phase (CP)-CML Ph+ patients with complete hematologic response (CHR) but without one log BCR-ABL reduction (BCR-ABL level \>10% IS) 3 months of imatinib 400mg treatment. (Imatinib transient dose adjustments due to Adverse Event (AEs) are allowed with a maximum of 2 weeks interruption of treatment with imatinib (cumulative) within the 3 month period before randomization). Imatinib monotherapy must have been started within 6 months of CP-CML diagnosis (Ph + /BCR-ABL detection)
Currently tolerating imatinib 400mg QD. Patients with prior imatinib treatment interruption or dose reductions are required to be on treatment with 400 mg imatinib for two weeks immediately prior to randomization to ensure tolerance to imatinib
Eastern Co-Operative Group (ECOG) performance status = 0 - 2
Adequate renal function defined as serum creatinine ≤3 times the institutional upper limit of normal (ULN)
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 ULN

Criterios de exclusión

Previous diagnosis of accelerated phase or blast crisis
Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases at baseline bone marrow cytogenetic test, unless the same abnormalities were present at diagnosis. Patients with no evidence of clonal evolution, including those patients whose cytogenetic testing fails or bone marrow aspiration is a dry tap at 3 months, are eligible for the study
Subjects with less than CHR after 3 months of imatinib treatment or lost CHR after initial achievement
Documented T315I/A, F317L, or V299L mutations (if already available - not required for screening)
A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy

Intervenciones

drug

Imatinib

drug

Dasatinib

Ubicaciones

Local Institution - 0093

La Plata, Buenos Aires, Argentina

Local Institution - 0080

Ramos Mejía, Buenos Aires, Argentina

Local Institution - 0049

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0051

Buenos Aires, Argentina

Local Institution - 0057

Buenos Aires, Argentina

Local Institution - 0100

Corrientes, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorICON Clinical Research

ColaboradorPPD Development, LP

ColaboradorMolecular MD

ColaboradorMultiPharma

ColaboradorQ2 Solutions

ColaboradorDonald E. Morisky

ColaboradorMD Anderson Symptom Inventory (MDASI-CML)

ColaboradorOBiS, Inc

ColaboradorSteering Committee

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