Dasatinib (BMS-354825) in Subjects With Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

NCT ID: NCT00101595

Last Updated: 2011-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-12-31

Brief Summary

The purpose of this clinical research study is to learn if BMS-354825 will have activity as defined by hematologic responses in subjects with lymphoid blast phase chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia with primary or acquired resistance to imatinib mesylate.

Conditions

Chronic Myeloid Leukemia; Leukemia, Lymphoblastic, Acute, Philadelphia-positive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Dasatinib

Intervention Type: DRUG

Tablets, Oral, 70 mg, twice daily, Until disease progression or untolerable toxicity, switch to the roll-over study or study closure

Interventions

Dasatinib

Tablets, Oral, 70 mg, twice daily, Until disease progression or untolerable toxicity, switch to the roll-over study or study closure

Intervention Type: DRUG

Other Intervention Names

BMS-354825; Sprycel

Eligibility Criteria

Inclusion Criteria

• Subjects with Philadelphia chromosome positive (Ph+) (BCR/ABL+) lymphoid blast phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
• Subjects who are considered to have lymphoid blast phase CML if they meet at least one of the following criteria: *30% lymphoid blasts in peripheral blood or bone marrow. *Extramedullary infiltrates of leukemic cells (other than in spleen or liver) with peripheral blood lymphoid blast morphology.
• ECOG performance status score 0-2.
• Adequate hepatic function defined as: *Total bilirubin less than or equal to 2.0 times the institutional upper limit of normal; *alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 times the institutional upper limit of normal.
• Adequate renal function defined as: *serum creatinine less than or equal to 1.5 times the institutional upper normal limit.
• Men and women, 18 years of age or older.
• 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. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IC/L or equivalent units of HCG) within 72 hours prior to the start of study medication.

Exclusion Criteria

• WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period of at least 1 month before and for at least 3 months after completion of the study medication.
• WOCBP using a prohibited contraceptive method (not applicable).
• Women who are pregnant or breastfeeding.
• Women with a positive pregnancy test on enrollment or prior to study drug administration.
• Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period and for at least 3 months after completion of study medication.
• Subjects who are eligible and willing to undergo transplantation during the screening period.
• A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
• Demential 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.
• Subjects who received any of the following:

• imatinib mesylate within 7 days;
• interferon or cytarabine within 14 days;
• a targeted small molecule anti-cancer agent within 14 days;
• any other investigational or antineoplastic agent other than hydroxyurea or anagrelide within 28 days before starting treatment with BMS-354825.
• Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes.
• Subjects taking medications that irreversibly inhibit platelet function.
• Prior therapy with BMS-354825.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Bristol-Myers Squibb

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Birmingham, Alabama, United States

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Anaheim, California, United States

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Los Angeles, California, United States

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Stanford, California, United States

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Vallejo, California, United States

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Jacksonville, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Kansas City, Kansas, United States

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Boston, Massachusetts, United States

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St Louis, Missouri, United States

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Hackensack, New Jersey, United States

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New York, New York, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Buenos Aires, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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St Leonards, New South Wales, Australia

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Vienna, , Austria

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B-Leuven, , Belgium

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Edegem, , Belgium

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Yvoir, , Belgium

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São Paulo, São Paulo, Brazil

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Campinas, , Brazil

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Aarhus, , Denmark

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Helsinki, , Finland

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Lille, , France

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Lyon, , France

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Nantes, , France

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Paris, , France

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Pessac, , France

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Poitiers, , France

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Strasbourg, , France

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Frankfurt am Main, , Germany

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Hamburg, , Germany

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Mainz, , Germany

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Mannheim, , Germany

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Ramat Gan, , Israel

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Bologna, , Italy

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Orbassano, , Italy

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Roma, , Italy

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Nijmegen, , Netherlands

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Rotterdam, , Netherlands

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Trondheim, , Norway

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Lima, Lima Province, Peru

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Kyunggi-Do, , South Korea

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Seoul, , South Korea

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Gothenburg, , Sweden

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Lund, , Sweden

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Stockholm, , Sweden

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Umeå, , Sweden

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Uppsala, , Sweden

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Basel, , Switzerland

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Glasgow, Central, United Kingdom

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London, Greater London, United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Denmark; Finland; France; Germany; Israel; Italy; Netherlands; Norway; Peru; South Korea; Sweden; Switzerland; United Kingdom

References

Cortes J, Rousselot P, Kim DW, Ritchie E, Hamerschlak N, Coutre S, Hochhaus A, Guilhot F, Saglio G, Apperley J, Ottmann O, Shah N, Erben P, Branford S, Agarwal P, Gollerkeri A, Baccarani M. Dasatinib induces complete hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in blast crisis. Blood. 2007 Apr 15;109(8):3207-13. doi: 10.1182/blood-2006-09-046888. Epub 2006 Dec 21.

Reference Type: BACKGROUND

PMID: 17185463 (View on PubMed)

Ottmann O, Dombret H, Martinelli G, Simonsson B, Guilhot F, Larson RA, Rege-Cambrin G, Radich J, Hochhaus A, Apanovitch AM, Gollerkeri A, Coutre S. Dasatinib induces rapid hematologic and cytogenetic responses in adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia with resistance or intolerance to imatinib: interim results of a phase 2 study. Blood. 2007 Oct 1;110(7):2309-15. doi: 10.1182/blood-2007-02-073528. Epub 2007 May 11.

Reference Type: BACKGROUND

PMID: 17496201 (View on PubMed)

Porkka K, Koskenvesa P, Lundan T, Rimpilainen J, Mustjoki S, Smykla R, Wild R, Luo R, Arnan M, Brethon B, Eccersley L, Hjorth-Hansen H, Hoglund M, Klamova H, Knutsen H, Parikh S, Raffoux E, Gruber F, Brito-Babapulle F, Dombret H, Duarte RF, Elonen E, Paquette R, Zwaan CM, Lee FY. Dasatinib crosses the blood-brain barrier and is an efficient therapy for central nervous system Philadelphia chromosome-positive leukemia. Blood. 2008 Aug 15;112(4):1005-12. doi: 10.1182/blood-2008-02-140665. Epub 2008 May 13.

Reference Type: BACKGROUND

PMID: 18477770 (View on PubMed)

Other Identifiers

CA180-015

Identifier Type: -

Identifier Source: org_study_id

NCT00110097

Identifier Type: -

Identifier Source: nct_alias