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Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myeloid Leukemia, Chronic, Accelerated Phase; Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

Intervention: dasatinib (Drug); dasatinib (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).

Clinical Details

Official title: A Randomized Two-Arm, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population

Secondary outcome:

Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population

Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population

Median Time to Major Hematologic Response (MaHR) - Randomized Population

Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study

Percent of Participants With Overall Hematologic Response - Randomized Population

Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population

Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population

Number of Participants With Best Cytogenic Response (CyR) - Randomized Population

Median Progression Free Survival (PFS) - Randomized Population

Median Overall Survival (OS) - Randomized Population

Progression Free Survival (PFS) and Overall Survival (OS) at 24, 36, 48, and 60 Months - Randomized Population

Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation and Drug-related Fluid Retention AEs, up to Year 7 in Treated Participants

Number of Participants With Normal Baseline Versus Worst Grade 3/4 Hematology Laboratory Abnormalities up to Year 2 in Treated Participants

Number of Participants With Grade 4 Myelosuppression Determined From Hematology Evaluations

Number of Participants With Normal Baseline Versus Worst Grade 3/4 Biochemistry Laboratory Abnormalities up to Year 2 in Treated Participants

Number of Participants With Changes From Baseline in QT Interval Corrected With Fridericia Formula (QTcF) up to Year 2 in Treated Participants

Number of Participants With Maximal QTcF Intervals up to Year 2 in Treated Participants

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

For more information regarding BMS clinical trial participation, please visit www. BMSStudyConnect. com. Inclusion Criteria:

- Patients with Philadelphia-Positive (Ph+) (or BCR/ABL+) accelerated phase chronic

myeloid leukemia, Ph+ (or BCR/ABL+) blast phase chronic myeloid leukemia, or Ph+ (or BCR/ABL+) acute lymphoblastic leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate

- Men and women, 18 years of age or older

- Adequate hepatic function

- Adequate renal function

- Women of childbearing potential (WOCBP) must be using an adequate method of

contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized

- Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2

Exclusion Criteria:

- Women who are pregnant or breastfeeding

- A serious uncontrolled medical disorder or active infection that would impair the

ability of the subject to receive protocol therapy

- Uncontrolled or significant cardiovascular disease

- Medications that increase bleeding risk

- Medications that change heart rhythms

- Dementia or altered mental status that would prohibit the understanding or rendering

of informed consent

- History of significant bleeding disorder unrelated to CML

- Concurrent incurable malignancy other than CML

- Evidence of organ dysfunction or digestive dysfunction that would prevent

administration of study therapy

- Prior therapy with BMS-35425

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for

treatment of either a psychiatric or physical (e. g., infectious disease) illness must not be enrolled into this study

Locations and Contacts

Local Institution, Wien 1090, Austria

Local Institution, B-leuven 3000, Belgium

Local Institution, Brugge 8000, Belgium

Local Institution, Bruxelles 1000, Belgium

Local Institution, Charleroi 6000, Belgium

Local Institution, Yvoir 5530, Belgium

Local Institution, Rio De Janeiro 20230-130, Brazil

Local Institution, Sao Paulo 05403-000, Brazil

Local Institution, Brno 62500, Czech Republic

Local Institution, Prague 2 128 20, Czech Republic

Local Institution, Aarhus C 8000, Denmark

Local Institution, Herlev 2730, Denmark

Local Institution, Odense C 5000, Denmark

Local Institution, Helsinki 00029, Finland

Local Institution, Caen Cedex 14033, France

Local Institution, Creteil Cedex 94010, France

Local Institution, Grenoble Cedex 9 38043, France

Local Institution, Lille Cedex 59037, France

Local Institution, Lyon Cedex 69437, France

Local Institution, Marseille Cedex 9 13273, France

Local Institution, Nantes 44000, France

Local Institution, Paris Cedex 10 75475, France

Local Institution, Pessac 33604, France

Local Institution, Poitiers Cedex 86021, France

Local Institution, Strasbourg Cedex 67091, France

Local Institution, Dresden 01307, Germany

Local Institution, Frankfurt 60596, Germany

Local Institution, Hamburg 20246, Germany

Local Institution, Leipzig 04103, Germany

Local Institution, Mainz 55131, Germany

Local Institution, Mannheim 68167, Germany

Local Institution, Athens 11523, Greece

Local Institution, Budapest 1135, Hungary

Local Institution, Dublin, Ireland

Local Institution, Ramat-gan 52621, Israel

Local Institution, Bari 70124, Italy

Local Institution, Bologna 40138, Italy

Local Institution, Monza 20052, Italy

Local Institution, Napoli 80131, Italy

Local Institution, Orbassano (to) 10043, Italy

Local Institution, Roma 00144, Italy

Local Institution, Jeollanam-do, Korea, Republic of

Local Institution, Seoul 110-744, Korea, Republic of

Local Institution, Seoul 137-040, Korea, Republic of

Local Institution, Seoul 138-736, Korea, Republic of

Local Institution, Rotterdam 3075 EA, Netherlands

Local Institution, Trondheim 7006, Norway

Local Institution, Lima 34, Peru

Local Institution, Quezon City 1102, Philippines

Local Institution, Gdansk 80211, Poland

Local Institution, Katowice 40032, Poland

Local Institution, Krakow 31501, Poland

Local Institution, Lodz 93510, Poland

Local Institution, Lublin 20950, Poland

Local Institution, Warsaw 02097, Poland

Local Institution, Moscow 125167, Russian Federation

Local Institution, St.petersburg 197022, Russian Federation

Local Institution, Singapore 169608, Singapore

Local Institution, Barcelona 08036, Spain

Local Institution, Madrid 28006, Spain

Local Institution, Madrid 28034, Spain

Local Institution, Valencia 46009, Spain

Local Institution, Lund 22185, Sweden

Local Institution, Stockholm 17176, Sweden

Local Institution, Umea 90185, Sweden

Local Institution, Uppsala 75185, Sweden

Local Institution, Basel 4031, Switzerland

Local Institution, Taipei 100, Taiwan

Local Institution, Taipei, Taiwan

Local Institution, Taoyuan 333, Taiwan

Local Institution, Bangkok 10400, Thailand

Local Institution, Edinburgh EH8 9RS, United Kingdom

Local Institution, Liverpool L7 8XP, United Kingdom

University Of Alabama At Birmingham, Birmingham, Alabama 35294, United States

Local Institution, Edmonton, Alberta T6G 1Z2, Canada

Local Institution, Vancouver, British Columbia V5Z 1M9, Canada

Local Institution, Capital Federal, Buenos Aires 1280, Argentina

Loma Linda University Cancer Center, Loma Linda, California 92354, United States

Ucla Dept. Of Medicine, Los Angeles, California 90095, United States

Washington Cancer Institute At Washington Hospital Center, Washington, District of Columbia 20010, United States

University Of Miami, Miami, Florida 33136, United States

Local Institution, Bloemfontein, Free State 9301, South Africa

Local Institution, Groenkloof, Gauteng 0181, South Africa

Local Institution, Parktown, Gauteng 2193, South Africa

Emory University School Of Medicine, Atlanta, Georgia 30322, United States

Local Institution, London, Greater London W12 ONN, United Kingdom

Northwestern University, Chicago, Illinois 60611, United States

The University Of Chicago, Chicago, Illinois 60637-1463, United States

Indiana University Cancer Center, Indianapolis, Indiana 46202, United States

University Of Kentucky, Lexington, Kentucky 40536-0098, United States

Local Institution, Jesus Maria, Lima 11, Peru

University Of Maryland, Baltimore, Maryland 21201-1595, United States

Dana Faber Cancer Institute, Boston, Massachusetts 02115, United States

Karmanos Cancer Center, Detroit, Michigan 48201, United States

Washington University School Of Medicine, Saint Louis, Missouri 63110-1093, United States

Devetten, Marcel, Omaha, Nebraska 68198-7680, United States

Nebraska Methodist Hospital, Omaha, Nebraska 68114, United States

The Cancer Center At Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

The Cancer Institute Of New Jersey, New Brunswick, New Jersey 08903, United States

Local Institution, St Leonards, New South Wales 2065, Australia

New York Presbyterian Hospital, New York, New York 10021, United States

The University Of North Carolina At Chapel Hill, Chapel Hill, North Carolina 27599-7305, United States

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

Oregon Health & Sci Univ, Portland, Oregon 97239, United States

Local Institution, Curitiba, Parana 80060-900, Brazil

Western Pennsylvania Cancer Institute, Pittsburgh, Pennsylvania 15224, United States

Local Institution, Montreal, Quebec H3A 1A1, Canada

Local Institution, South Brisbane, Queensland 4101, Australia

Local Institution, Campinas, Sao Paulo 13083-970, Brazil

Local Institution, Morumbi, Sao Paulo 05652-000, Brazil

Local Institution, Glasgow, Scotland G12 OXB, United Kingdom

Local Institution, Adelaide, South Australia SA 5000, Australia

Sarah Cannon Research Institute, Nashville, Tennessee 37203, United States

The University Of Texas Md Anderson Cancer Center, Houston, Texas 77030, United States

Local Institution, Newcastle, Tyne And Wear NE2 4HH, United Kingdom

Local Institution, Parkville, Victoria 3050, Australia

Seattle Cancer Care Alliance, Seattle, Washington 98109, United States

Local Institution, Perth, Western Australia WA 6000, Australia

Local Institution, Observatory, Western Cape 7925, South Africa

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: June 2005
Last updated: October 30, 2014

Page last updated: August 23, 2015

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