Myeloproliferative Neoplasms Clinical Trial
Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib
Summary
The purpose of this study is to test the hypothesis that patients with leukemia-cml/" >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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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There are 99 Locations for this study
Anaheim California, 92801, United States
Fontana California, 92335, United States
Los Angeles California, 90033, United States
Roseville California, 95661, United States
San Jose California, 95119, United States
Vallejo California, 94589, United States
Whittier California, 90603, United States
Southington Connecticut, 06489, United States
Evanston Illinois, 60208, United States
Urbana Illinois, 61801, United States
Crown Point Indiana, 46307, United States
Indianapolis Indiana, 46237, United States
Iowa City Iowa, 52242, United States
Rochester Minnesota, 55905, United States
Cincinnati Ohio, 45242, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Laredo Texas, 78041, United States
Huntington West Virginia, 25701, United States
Milwaukee Wisconsin, 53226, United States
La Plata Buenos Aires, 0, Argentina
Ramos Mejia Buenos Aires, 1221, Argentina
San Miguel de Tucuman Tucuman, 4000, Argentina
Buenos Aires , 4102-, Argentina
Buenos Aires , C1114, Argentina
Corrientes , CP340, Argentina
Innsbruck Tyrol, 6020, Austria
Wels Upper Austria, 4600, Austria
Fuerstenfeld , 8280, Austria
Graz , 8036, Austria
Linz , 4010, Austria
Wien , 1090 , Austria
Brugge , B-800, Belgium
Merksem , 2170, Belgium
Yvoir , 5530, Belgium
Goiania Goias, 74605, Brazil
Curitiba Parana, 80060, Brazil
Campinas SAO Paulo, 13083, Brazil
Ribeirão Preto SAO Paulo, 14048, Brazil
São Paulo SAO Paulo, 08270, Brazil
Rio de Janeiro , 20211, Brazil
Rio de Janeiro , 20231, Brazil
Rio de Janeiro , 20231, Brazil
Saint John New Brunswick, E2L 4, Canada
Beijing Beijing, 10004, China
Beijing Beijing, 10007, China
Fuzhou Fujian, 35000, China
Shenzhen Guandong, 51803, China
Guangzhou Guangdong, 51008, China
Guangzhou Guangdong, 51051, China
Haerbin Heilongjiang, 15001, China
Wuhan Hubei, 43003, China
Nanjing Jiangsu, 21002, China
Suzhou Jiangsu, 21500, China
Shenyang Liaoning, 11000, China
Xian Shan3xi, 71000, China
Jinan Shandong, 25001, China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, 30002, China
Hangzhou , 31000, China
Shanghai , 20002, China
Wuhan , 43003, China
Brno Czech Republic, 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Olomouc , 775 2, Czechia
Prague 10 , 100 3, Czechia
Prague 2 , 12808, Czechia
Le Chesnay Cedex , 78157, France
Lille cedex , 59037, France
Nantes , 44000, France
Pierre Bénite cedex , 69495, France
Vandoeuvre-les-Nancy Cedex , 54511, France
Budapest , 1083, Hungary
Szeged , 6725, Hungary
Brescia Province Of Brescia, 25123, Italy
Bari , 70124, Italy
Bologna , 40138, Italy
Catania , 95124, Italy
Firenze , 50134, Italy
Monza , 20900, Italy
Napoli , 80131, Italy
Orbassano , 10143, Italy
Roma , 00144, Italy
Rome , 00161, Italy
Seoul , 06351, Korea, Republic of
Seoul , 137-7, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Krakow Malopolskie, 30-51, Poland
Gdansk , 80-95, Poland
Katowice , 40-03, Poland
Warsaw , 02-77, Poland
A Couruna , 15706, Spain
L'Hospitalet Del Llobregat , 08908, Spain
Las Palmas de Gran Canaria , 35010, Spain
Madrid , 28007, Spain
Salamanca , 37007, Spain
Toledo , 45004, Spain
Muang Chiang Mai, 50200, Thailand
Bangkok , 10400, Thailand
Khon Kaen , 40002, Thailand
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