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.

View Eligibility Criteria

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

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

262

Study ID:

NCT01593254

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 99 Locations for this study

See Locations Near You

Local Institution - 0004
Anaheim California, 92801, United States
Local Institution - 0006
Fontana California, 92335, United States
University Of Southern California University Hospital
Los Angeles California, 90033, United States
Kaiser Permanente Medical Center
Oakland California, 94611, United States
Kaiser Permanente Oncology Clinical Trials
San Jose California, 95119, United States
Kaiser Permanente Oncology Clinical Trials
Vallejo California, 94589, United States
Local Institution - 0078
Whittier California, 90603, United States
Local Institution - 0089
Southington Connecticut, 06489, United States
Northwestern University
Evanston Illinois, 60208, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
Northern Indiana Cancer Research Consortium
Crown Point Indiana, 46307, United States
Franciscan St. Francis Health
Indianapolis Indiana, 46237, United States
University Of Iowa
Iowa City Iowa, 52242, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Local Institution - 0002
Cincinnati Ohio, 45242, United States
Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Local Institution - 0001
Nashville Tennessee, 37203, United States
Michael E Debakey VAMC
Houston Texas, 77030, United States
Institute of Oncology Hematology Biomedical Research
Laredo Texas, 78041, United States
Edwards Comprehensive Cancer Center
Huntington West Virginia, 25701, United States
Local Institution - 0005
Milwaukee Wisconsin, 53226, United States
Local Institution - 0093
La Plata Buenos Aires, 0, Argentina
Local Institution - 0080
Ramos Mejia Buenos Aires, 1221, Argentina
Local Institution - 0049
San Miguel de Tucuman Tucuman, 4000, Argentina
Local Institution - 0051
Buenos Aires , 4102-, Argentina
Local Institution
Buenos Aires , C1114, Argentina
Local Institution - 0100
Corrientes , CP340, Argentina
Local Institution - 0026
Innsbruck Tyrol, 6020, Austria
Local Institution
Fuerstenfeld , 8280, Austria
Local Institution - 0043
Graz , 8036, Austria
Local Institution - 0024
Linz , 4010, Austria
Local Institution
Wels , 4600, Austria
Local Institution - 0023
Wien , 1090 , Austria
Local Institution - 0065
Brugge , B-800, Belgium
Local Institution - 0099
Merksem , 2170, Belgium
Local Institution
Yvoir , 5530, Belgium
Local Institution
Goiania Goias, 74605, Brazil
Local Institution
Curitiba Parana, 80060, Brazil
Local Institution - 0063
Campinas SAO Paulo, 13083, Brazil
Local Institution
Ribeirão Preto SAO Paulo, 14048, Brazil
Local Institution - 0059
São Paulo SAO Paulo, 08270, Brazil
Local Institution - 0062
Rio de Janeiro , 20211, Brazil
Local Institution - 0111
Rio de Janeiro , 20231, Brazil
Local Institution
Rio de Janeiro , 20231, Brazil
Local Institution - 0020
Saint John New Brunswick, E2L 4, Canada
Local Institution - 0071
Beijing Beijing, 10004, China
Local Institution - 0086
Beijing Beijing, 10007, China
Local Institution - 0070
Fuzhou Fujian, 35000, China
Local Institution - 0103
Shenzhen Guandong, 51803, China
Local Institution - 0082
Guangzhou Guangdong, 51008, China
Local Institution - 0074
Guangzhou Guangdong, 51051, China
Local Institution - 0084
Haerbin Heilongjiang, 15001, China
Local Institution - 0102
Wuhan Hubei, 43003, China
Local Institution - 0073
Nanjing Jiangsu, 21002, China
Local Institution - 0077
Suzhou Jiangsu, 21500, China
Local Institution - 0094
Shenyang Liaoning, 11000, China
Local Institution - 0088
Xian Shan3xi, 71000, China
Local Institution - 0101
Jinan Shandong, 25001, China
Local Institution - 0075
Chengdu Sichuan, 61004, China
Local Institution - 0069
Tianjin Tianjin, 30002, China
Local Institution - 0072
Hangzhou , 31000, China
Local Institution - 0076
Shanghai , 20002, China
Local Institution - 0096
Wuhan , 43003, China
Local Institution - 0032
Brno Czech Republic, 625 0, Czechia
Local Institution
Hradec Kralove , 500 0, Czechia
Local Institution
Olomouc , 775 2, Czechia
Local Institution
Prague 10 , 100 3, Czechia
Local Institution - 0067
Prague 2 , 12808, Czechia
Local Institution - 0045
Le Chesnay Cedex , 78157, France
Local Institution - 0041
Lille cedex , 59037, France
Local Institution
Nantes , 44000, France
Local Institution
Pierre Bénite cedex , 69495, France
Local Institution - 0038
Vandoeuvre-les-Nancy Cedex , 54511, France
Local Institution
Budapest , 1083, Hungary
Local Institution - 0104
Szeged , 6725, Hungary
Local Institution - 0106
Brescia Province Of Brescia, 25123, Italy
Local Institution
Bari , 70124, Italy
Local Institution
Bologna , 40138, Italy
Local Institution
Catania , 95124, Italy
Local Institution - 0027
Firenze , 50134, Italy
Local Institution - 0046
Monza , 20900, Italy
Local Institution
Napoli , 80131, Italy
Local Institution - 0025
Orbassano , 10143, Italy
Local Institution - 0021
Roma , 00144, Italy
Local Institution - 0033
Rome , 00161, Italy
Local Institution - 0039
Seoul , 06351, Korea, Republic of
Local Institution - 0050
Seoul , 137-7, Korea, Republic of
Local Institution
Seoul , 138-7, Korea, Republic of
Local Institution - 0048
Krakow Malopolskie, 30-51, Poland
Local Institution - 0047
Gdansk , 80-95, Poland
Local Institution - 0098
Katowice , 40-03, Poland
Local Institution - 0064
Warsaw , 02-77, Poland
Local Institution
L'Hospitalet Del Llobregat , 08908, Spain
Local Institution
Las Palmas de Gran Canaria , 35010, Spain
Local Institution - 0012
Madrid , 28007, Spain
Local Institution - 0013
Salamanca , 37007, Spain
Local Institution
Santiago de Compostela , 15706, Spain
Local Institution
Toledo , 45004, Spain
Local Institution - 0055
Muang Chiang Mai, 50200, Thailand
Local Institution
Bangkok , 10400, Thailand
Local Institution - 0052
Khon Kaen , 40002, Thailand

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

262

Study ID:

NCT01593254

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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