Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib

Completed · Phase 2

Conditions studied: Chronic Phase Chronic Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT01593254

Run by

Bristol-Myers Squibb

People needed

262

Starts

2012-09-12

Expected to finish

2022-04-12

Last updated by the study team

2023-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0006 — Fontana, California, United States
• University Of Southern California University Hospital — Los Angeles, California, United States
• Local Institution - 0110 — Roseville, California, United States
• Local Institution - 0112 — San Jose, California, United States
• Local Institution - 0009 — Vallejo, California, United States
• Local Institution - 0078 — Whittier, California, United States
• Local Institution - 0089 — Southington, Connecticut, United States
• Northwestern University — Evanston, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• Northern Indiana Cancer Research Consortium — Crown Point, Indiana, United States
• Franciscan St. Francis Health — Indianapolis, Indiana, United States
• University Of Iowa — Iowa City, Iowa, United States
• Local Institution - 0010 — Rochester, Minnesota, United States
• Local Institution - 0002 — Cincinnati, Ohio, United States
• Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Local Institution - 0001 — Nashville, Tennessee, United States
• Michael E Debakey VAMC — Houston, Texas, United States
• Institute of Oncology Hematology Biomedical Research — Laredo, Texas, United States
• Edwards Comprehensive Cancer Center — Huntington, West Virginia, United States
• Local Institution - 0005 — Milwaukee, Wisconsin, United States
• 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 - 0004 — Anaheim, California, United States

Full record on ClinicalTrials.gov

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