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Chronic Myeloid LeukemiaPhase 2NCT00101595

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

A Phase 2 study testing Dasatinib in people with Chronic Myeloid Leukemia and Leukemia, Lymphoblastic, Acute, Philadelphia-positive, run by Bristol-Myers Squibb at 60 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dasatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
60 sitesin 20 countries
Study dates
Jan 2005to Dec 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

60 sites in 20 countries.

60 sites in 20 countries

United States18 sites

  • Local Institution

    Anaheim, California

  • Local Institution

    Atlanta, Georgia

  • Local Institution

    Birmingham, Alabama

  • Local Institution

    Boston, Massachusetts

  • Local Institution

    Chicago, Illinois

  • Local Institution

    Hackensack, New Jersey

  • Local Institution

    Houston, Texas

  • Local Institution

    Jacksonville, Florida

  • Local Institution

    Kansas City, Kansas

  • Local Institution

    Los Angeles, California

  • Local Institution

    Nashville, Tennessee

  • Local Institution

    New York, New York

  • Local Institution

    Pittsburgh, Pennsylvania

  • Local Institution

    Portland, Oregon

  • Local Institution

    St Louis, Missouri

  • Local Institution

    Stanford, California

  • Local Institution

    Tampa, Florida

  • Local Institution

    Vallejo, California

Other trials in United States

France7 sites

  • Local Institution

    Lille

  • Local Institution

    Lyon

  • Local Institution

    Nantes

  • Local Institution

    Paris

  • Local Institution

    Pessac

  • Local Institution

    Poitiers

  • Local Institution

    Strasbourg

Other trials in France

Sweden5 sites

  • Local Institution

    Gothenburg

  • Local Institution

    Lund

  • Local Institution

    Stockholm

  • Local Institution

    Umeå

  • Local Institution

    Uppsala

Other trials in Sweden

Germany4 sites

  • Local Institution

    Frankfurt am Main

  • Local Institution

    Hamburg

  • Local Institution

    Mainz

  • Local Institution

    Mannheim

Other trials in Germany

Belgium3 sites

  • Local Institution

    B-Leuven

  • Local Institution

    Edegem

  • Local Institution

    Yvoir

Other trials in Belgium

Italy3 sites

  • Local Institution

    Bologna

  • Local Institution

    Orbassano

  • Local Institution

    Roma

Other trials in Italy

Argentina2 sites

  • Local Institution

    Buenos Aires, Buenos Aires

  • Local Institution

    Córdoba, Córdoba Province

Other trials in Argentina

Brazil2 sites

  • Local Institution

    Campinas

  • Local Institution

    São Paulo, São Paulo

Other trials in Brazil

Canada2 sites

  • Local Institution

    Montreal, Quebec

  • Local Institution

    Toronto, Ontario

Other trials in Canada

Netherlands2 sites

  • Local Institution

    Nijmegen

  • Local Institution

    Rotterdam

Other trials in Netherlands

South Korea2 sites

  • Local Institution

    Kyunggi-Do

  • Local Institution

    Seoul

Other trials in South Korea

United Kingdom2 sites

  • Local Institution

    Glasgow, Central

  • Local Institution

    London, Greater London

Other trials in United Kingdom

Australia1 site

  • Local Institution

    St Leonards, New South Wales

Other trials in Australia

Austria1 site

  • Local Institution

    Vienna

Other trials in Austria

Denmark1 site

  • Local Institution

    Aarhus

Other trials in Denmark

Finland1 site

  • Local Institution

    Helsinki

Other trials in Finland

Israel1 site

  • Local Institution

    Ramat Gan

Other trials in Israel

Norway1 site

  • Local Institution

    Trondheim

Other trials in Norway

Peru1 site

  • Local Institution

    Lima, Lima Province

Other trials in Peru

Switzerland1 site

  • Local Institution

    Basel

Other trials in Switzerland

About this study

Official title: A Phase II Study of BMS-354825 in Subjects With Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate

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.

Being tested
Dasatinib
Keywords
Lymphoid blast phase chronic myeloid leukemia, Philadelphia chromosome positive acute lymphoblastic leukemia
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DasatinibDrug

    Also called BMS-354825, Sprycel

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

Study groups in NCT00101595
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Dasatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major and overall hematologic response rates

    Measured: throughout the study

Secondary outcomes (7)

  1. Durability of hematologic response and time to hematologic response (major and overall)

    Measured: throughout the study

  2. Assess cytogenetic and molecular responses

    Measured: throughout the study

  3. Measure minor hematologic response rate in the imatinib resistant group

    Measured: throughout the study

  4. Explore the role of BCR-ABL mRNA expression and point mutations in the BCR-ABL gene

    Measured: throughout the study

  5. Measure the heath-related QOL using FACT-G

    Measured: throughout the study

  6. To assess safety and tolerability of dasatinib

    Measured: throughout the study

  7. Population PK

    Measured: first month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00101595
Sponsor's protocol ID
CA180-015
Status last verified
Apr 2011
First submitted
12 Jan 2005
Last updated
14 Apr 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17185463

  • 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.

    PubMed 17496201

  • 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.

    PubMed 18477770

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dasatinib in people with Chronic Myeloid Leukemia and Leukemia, Lymphoblastic, Acute, Philadelphia-positive, run by Bristol-Myers Squibb at 60 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, France, Sweden, Germany, Belgium and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major and overall hematologic response rates (time frame: throughout the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00101595, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2011.

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