An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Participants With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Blast Crisis
Condition: Philadelphia Chromosome Positive CML
MeSH terms: Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Blast Crisis; Philadelphia Chromosome
Intervention: imatinib mesylate
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Myelogenous Leukemia; CML; Philadelphia Chromosome; Blast crisis; Imatinib mesylate

Summary:

      This extension II study allowed for further follow-up of the disease under treatment with
      imatinib mesylate and allow the participants to continue to receive imatinib mesylate.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Participants with Philadelphia chromosome positive chronic myelogenous leukemia (CML) in
        myeloid blast crisis (including both newly diagnosed and the participants who received
        prior therapy for accelerated or blastic phases), defined as either:

          1. ≥ 30% blast in peripheral blood and /or bone marrow

          2. by flow cytometry criteria

        2. To be categorized as "newly diagnosed", participants with CML in blast crisis were not
        to have received specific therapy for CML accelerated or blast phases, with the exception
        of interferon-alpha or hydroxyurea.

        3. serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase
        (SGPT) not more than 3 times the upper limit of the normal range (ULN) (or not more than 5
        times the ULN if clinically suspected leukemic involvement of the liver), serum creatinine
        concentration not more than 2 times the ULN, and total serum bilirubin level not more than
        3 times the ULN at the laboratory where the analyses were performed.

        4. A negative pregnancy test in participants of childbearing potential.

        Exclusion Criteria:

          1. Participants with an eastern cooperative oncology group (ECOG) performance status
             score ≥ 3.

          2. Participants previously treated for blast crisis were not to have received any of the
             following with respect to Day 1 of the study: busulfan within six weeks,
             interferon-alpha within 48-hours, hydroxyurea within 24-hours, homoharringtonine
             within 14 days, low-dose, moderate dose or high dose cytosine arabinoside within 7, 14
             and 28 days respectively, anthracyclines, mitoxantrone, or etoposide within 21 days.

          3. Participants receiving any hematopoietic stem cell transplantation within six weeks of
             Day 1.

          4. Participants receiving any other investigational agents within 28 days of Day 1.

          5. Participants with Grade 3/4 cardiac disease or any other serious concurrent medical
             conditions.

        Other protocol-defined inclusion/exclusion criteria may apply.