A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+... | NCT00777036 | Trialant

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+... | NCT00777036 | Trialant

Ages Eligible for Study: Child (0-17)Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

CP-CML who prove resistant or intolerant to imatinib (Cohort 1)

Ph+ ALL, AP-CML, or BP-CML who are resistant or intolerant to or who relapse after imatinib therapy (Cohort 2)

Newly diagnosed, treatment naive CP-CML (Cohort 3)

Lansky or Karnofsky scale >50

Life expectancy ≥12 weeks

Adequate hepatic and renal function

Written informed consent

Target Population for the PK substudy must obtain written informed consent from subject, or from parents or legal guardians for minor subjects, according to local law and regulation

Target Population for the PK substudy subjects must have CP-CML and be taking daily dasatinib (tablets or PFOS) either as part of Cohort 1 or Cohort 3 of this protocol. Patients receiving commercial dasatinib tablets outside of this protocol may be invited to participate in this PK substudy

Target Population for the PK substudy subjects with CP-CML who are tolerating dasatinib tablet dose of at least 60 mg/m2 or dasatinib PFOS dose of at least 72 mg/m2

Target Population for the PK substudy prior exposure to imatinib or other TKI therapy is permissible

Target Population for the PK substudy subjects must meet relevant inclusion criteria

Exclusion Criteria:

Eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation

Symptomatic CNS involvement (other than signs and symptoms caused by leptomeningeal disease)

Isolated extramedullary disease

Prior therapy with Dasatinib

Target Population for the PK substudy subjects participating in the PK substudy must comply with the relevant exclusion criteria

Target Population for the PK substudy subjects are not allowed to use proton pump inhibitors, H2 antagonists, CYP3A4 inhibitors and inducers when entering the PK substudy

Other inclusion/exclusion criteria may apply

Local Institution

Birmingham, Alabama 35233, United States

Local Institution - 0005

Phoenix, Arizona 85016, United States

Phoenix Children'S Hospital

Phoenix, Arizona 85016, United States

Jonathan Jaques Children'S Cancer Center

Long Beach, California 90801-1428, United States

Jonathan Jaques Children'S Cancer Center

Long Beach, California 90806, United States

Local Institution - 0001

Long Beach, California 90806, United States

Children'S Hospital Of Orange County

Orange, California 92868, United States

Local Institution - 0024

Orange, California 92868, United States

Children'S Hospital

Aurora, Colorado 80045, United States

Local Institution - 0004

Aurora, Colorado 80045, United States

Children's Healthcare Of Atlanta - Egleston

Atlanta, Georgia 30322, United States

Local Institution - 047

Atlanta, Georgia 30322, United States

Children's Hospital of Chicago

Chicago, Illinois 60611, United States

Local Institution - 0072

Chicago, Illinois 60611, United States

Local Institution

Chicago, Illinois 60611, United States

Dana Faber Cancer Institute

Boston, Massachusetts 02215, United States

Dana Farber Cancer Institute.

Boston, Massachusetts 02215, United States

Local Institution - 0040

Boston, Massachusetts 02215, United States

Stephen D. Hassenfeld Children'S Center

New York, New York 10016, United States

Local Institution - 0061

New York, New York 10021, United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065, United States

Memorial Sloan Kettering Nassau

New York, New York 10065, United States

Oregon Health & Sci Univ

Portland, Oregon 97239-3098, United States

Local Institution - 0002

Portland, Oregon 97239, United States

Oregon Health & Sci Univ

Portland, Oregon 97239, United States

Children'S Hospital Of Philadelphia

Philadelphia, Pennsylvania 19104-4318, United States

Local Institution - 0014

Philadelphia, Pennsylvania 19104-4318, United States

Children'S Hospital Of Pittsburgh

Pittsburgh, Pennsylvania 15224, United States

Local Institution - 0003

Pittsburgh, Pennsylvania 15224, United States

Local Institution - 0035

Houston, Texas 77030-4009, United States

MD Anderson Cancer Center

Houston, Texas 77030-4009, United States

Local Institution - 0048

Houston, Texas 77030, United States

Texas Children'S Cancer Center

Houston, Texas 77030, United States

Local Institution - 0028

Seattle, Washington 98105, United States

Seattle Children'S

Seattle, Washington 98105, United States

Local Institution - 0043

Bunos Aires, Buenos Aires 1425, Argentina

Local Institution

Bunos Aires, Buenos Aires 1425, Argentina

Hospital Nacional Profesor Alejandro Posadas

El Palomar, Buenos Aires 1684, Argentina

Local Institution - 0049

El Palomar, Buenos Aires 1684, Argentina

Local Institution - 0042

Córdoba, 5016, Argentina

Local Institution

Córdoba, 5016, Argentina

Local Institution - 065

Randwick, New South Wales 2031, Australia

Local Institution

Randwick, New South Wales 2031, Australia

Local Institution - 069

Westmead, New South Wales 2145, Australia

Local Institution

Westmead, New South Wales 2145, Australia

Local Institution - 0064

Sth Brisbane, Queensland 4101, Australia

Local Institution

Sth Brisbane, Queensland 4101, Australia

Local Institution - 067

North Adelaide, South Australia 5006, Australia

Local Institution

North Adelaide, South Australia 5006, Australia

Local Institution - 0066

Parkville, Victoria 3052, Australia

Local Institution

Parkville, Victoria 3052, Australia

Local Institution - 0021

Curitiba, Paraná 80060-900, Brazil

Local Institution

Curitiba, Paraná 80060-900, Brazil

Local Institution - 0022

Porto Alegre, Rio Grande do Sul 90035-003, Brazil

Local Institution

Porto Alegre, Rio Grande do Sul 90035-003, Brazil

Local Institution - 0019

São Paulo, São Paulo 04520-013, Brazil

Local Institution - 0020

Campinas, 13083-970, Brazil

Local Institution

Campinas, 13083-970, Brazil

Local Institution - 0039

São Paulo, 01401-000, Brazil

Local Institution

São Paulo, 01401-000, Brazil

Local Institution

São Paulo, 04023-062, Brazil

Alberta Children'S Hospital

Calgary, Alberta T3B 6A8, Canada

Local Institution - 0079

Calgary, Alberta T3B 6A8, Canada

Local Institution - 0078

Edmonton, Alberta T6G 2B7, Canada

Stollery Children'S Hospital

Edmonton, Alberta T6G 2B7, Canada

Bc Children'S Hospital

Vancouver, British Columbia V6H 3V4, Canada

Local Institution - 077

Vancouver, British Columbia V6H 3V4, Canada

Iwk Health Centre

Halifax, Nova Scotia B3K 6R8, Canada

Local Institution - 073

Halifax, Nova Scotia B3K 6R8, Canada

Children'S Hospital Of Eastern Ontario

Ottawa, Ontario K1H 8L1, Canada

Local Institution - 086

Ottawa, Ontario K1H 8L1, Canada

Local Institution - 076

Toronto, Ontario M5G 1X8, Canada

The Hospital For Sick Children

Toronto, Ontario M5G 1X8, Canada

Chu Ste-Justine

Montreal, Quebec H3T 1C5, Canada

Local Institution - 080

Montreal, Quebec H3T 1C5, Canada

Local Institution - 0030

Lyon, 69008, France

Local Institution

Lyon, 69008, France

Local Institution - 0032

Nantes, 44093, France

Local Institution

Nantes, 44093, France

Local Institution - 0037

Paris, 75012, France

Local Institution

Paris, 75012, France

Local Institution

Paris, 75571, France

Local Institution - 0029

Paris, 75935, France

Local Institution

Paris, 75935, France

Local Institution - 036

Poitiers, 86000, France

Local Institution

Poitiers, 86000, France

Local Institution - 075

Frankfurt, 60590, Germany

Local Institution

Frankfurt, 60590, Germany

Local Institution - 0074

Hanover, 30625, Germany

Local Institution

Hanover, 30625, Germany

Local Institution - 0089

Navrangpura, Ahmedabad, Gujarat 380009, India

Local Institution

Navrangpura, Ahmedabad, Gujarat 380009, India

Local Institution

Bangalore, Karnataka 560027, India

Local Institution

Mumbai, Maharashtra 400010, India

Local Institution - 0094

Pune, Maharashtra 411001, India

Local Institution

Pune, Maharashtra 411001, India

Local Institution - 0093

Madurai, Tamil Nadu 625107, India

Local Institution

Madurai, Tamil Nadu 625107, India

Local Institution

Vellore, Tamil Nadu 632004, India

Local Institution - 0088

Bangalore, 560027, India

Local Institution - 0082

Kolkata, 700 016, India

Local Institution

Kolkata, 700 016, India

Local Institution - 0085

Mumbai, 400010, India

Local Institution

Mumbai, 400010, India

Local Institution - 0084

Trivandrum, 695011, India

Local Institution

Trivandrum, 695011, India

Local Institution - 038

Bologna, 40138, Italy

Local Institution

Bologna, 40138, Italy

Local Institution - 006

Monza, 20900, Italy

Local Institution

Monza (MB), 20900, Italy

Local Institution - 070

Roma, 00161, Italy

Local Institution

Roma, 00161, Italy

Local Institution - 0059

Roma, 00165, Italy

Local Institution

Roma, 00165, Italy

Local Institution - 015

Torino, 10126, Italy

Local Institution

Torino, 10126, Italy

Hospital Civil De Guadalajara - Nuevo Dr. Juan I. Menchaca

Guadalajara, Jalisco 44340, Mexico

Local Institution - 0054

Guadalajara, Jalisco 44340, Mexico

Local Institution - 0051

Cuauhtémoc, Mexico City 06720, Mexico

Local Institution

Df, Mexico City 06720, Mexico

Local Institution - 0053

Mexico City, Mexico City 04530, Mexico

Local Institution

Mexico City, Mexico City 04530, Mexico

Local Institution - 0052

Mexico City, Mexico City 06726, Mexico

Local Institution

Mexico City, Mexico City 06726, Mexico

Local Institution

Mexico, D. F., Mexico City 06726, Mexico

Local Institution - 0050

Monterrey, Nuevo León 64460, Mexico

Local Institution

Monterrey, Nuevo León 64460, Mexico

Local Institution - 0060

Monterrey, N.l., Nuevo León 64180, Mexico

Local Institution

Monterrey, N.l., Nuevo León 64180, Mexico

Local Institution - 0007

Rotterdam, 3015 GJ, Netherlands

Local Institution

Rotterdam, 3015 GJ, Netherlands

Local Institution - 0099

Utrecht, 3584 CS, Netherlands

Local Institution - 0095

Bucharest, 022322, Romania

Local Institution

Bucharest, 022322, Romania

Local Institution - 0097

Sector 2, 022328, Romania

Local Institution - 0017

Moscow, 115478, Russia

Local Institution

Moscow, 115478, Russia

Local Institution - 0023

Moscow, 117198, Russia

Local Institution

Moscow, 117198, Russia

Local Institution - 0018

Saint Petersburg, 197022, Russia

Local Institution

Saint Petersburg, 197022, Russia

Local Institution - 0071

Singapore, 119074, Singapore

Local Institution

Singapore, 119228, Singapore

Local Institution - 0055

Bloemfontein, Free State 9301, South Africa

Local Institution

Bloemfontein, Free State 9301, South Africa

Local Institution - 058

Pretoria, Gauteng 0001, South Africa

Local Institution

Pretoria, Gauteng 0001, South Africa

Local Institution - 0057

Cape Town, Western Cape 7925, South Africa

Local Institution

Cape Town, Western Cape 7925, South Africa

Local Institution - 062

Tygerberg, Western Cape 7505, South Africa

Local Institution

Tygerberg, Western Cape 7505, South Africa

Local Institution - 0092

Seoul, 05505, South Korea

Local Institution

Seoul, 05505, South Korea

Local Institution - 0091

Seoul, 137-701, South Korea

Local Institution

Seoul, 137-701, South Korea

Local Institution - 0013

Barcelona, 08025, Spain

Local Institution

Barcelona, 08025, Spain

Local Institution - 0012

Barcelona, 08035, Spain

Local Institution

Barcelona, 08035, Spain

Local Institution - 0011

Madrid, 28009, Spain

Local Institution

Madrid, 28009, Spain

Local Institution - 0010

Madrid, 28046, Spain

Local Institution

Madrid, 28046, Spain

Local Institution - 0041

Málaga, 29010, Spain

Local Institution

Málaga, 29010, Spain

Local Institution - 0033

Valencia, 46009, Spain

Local Institution

Valencia, 46009, Spain

Local Institution

Valencia, Spain

Local Institution - 0016

Glasgow, Central G3 8SJ, United Kingdom

Local Institution

Glasgow, Central G3 8SJ, United Kingdom

Local Institution - 0009

Sutton, Surrey SM2 5PT, United Kingdom

Local Institution

Sutton, Surrey SM2 5PT, United Kingdom

Local Institution - 0008

Birmingham, West Midlands B4 6NH, United Kingdom

Local Institution

Birmingham, West Midlands B4 6NH, United Kingdom