An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph+ Leukemia
Condition: Philadelphia Positive Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Intervention: STI571 400 mg; STI571 600 mg
Intervention description: STI571 capsules and tablets; STI571 capsules and tablets
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 293.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Myelogenous Leukemia; CML; Philadelphia Chromosome; Accelerated phase; Acute Myelogenous Leukemia; AML; Acute Lymphoblastic Leukemia; ALL; Imatinib mesylate

Summary:

      The objectives of Part 1 of the study were:

        -  To determine the rate of hematologic response (HR) lasting ≥4 weeks in participants with
           Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the accelerated
           phase (AP).

        -  To evaluate duration of HR, overall survival, cytogenetic response (CyR), time to blast
           crisis in CML participants in the AP, improvement of symptomatic parameters,
           tolerability and safety of STI571 treatment.

      The objective of the extension (Part 2) was:

      -To enable participants to have access to study drug and continue study treatment and to
      decrease data collection to include only overall survival and serious adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants, aged ≥18 years, with a histologically confirmed diagnosis
             of Ph+ leukemia of one of the following types:

               -  Accelerated phase chronic myeloid/myelogenous leukemia (CML).

               -  Acute lymphoid/lymphoblastic leukemia (ALL) or acute myeloid/myelogenous leukemia
                  (AML) in first or subsequent relapse after either standard chemotherapy,
                  autologous or allogeneic bone marrow transplantation, or high-dose treatment with
                  peripheral blood stem cell support, or

               -  ALL or AML refractory to standard chemotherapy (no complete remission achieved
                  after two courses of conventional induction chemotherapy).

               -  Lymphoid blastic phase of CML in first or subsequent relapse or refractory to
                  standard chemotherapy.

          -  With serum serum glutamate oxaloacetate transaminase (aspartate aminotransferase) and
             serum glutamate pyruvate transaminase (alanine aminotransferase) not more than 3 x
             upper limit of normal (ULN) (or not more than 5xULN if clinically suspected leukemic
             involvement of the liver), serum creatinine concentration not more than 2xULN, and
             total serum bilirubin level not more than 3xULN (bilirubin limit was 1.5xULN before
             protocol amendment 1)

        Exclusion Criteria:

          -  Participants who had an Eastern Cooperative Oncology Group (ECOG) performance status
             score ≥3.

          -  Participants with known leukemic involvement of the central nervous system (CNS).

          -  Participants who had received treatment with any of the following agents:
             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
             or 28 days respectively, 6-mercaptopurine, vinca alkaloids or steroids within 7 days,
             anthracyclines, mitoxantrone, etoposide, methotrexate, cyclophosphamide within 21
             days, or busulfan within 6 weeks.

          -  Participants who had undergone hematopoietic stem cell transplantation within six
             weeks of Day 1, or who had not achieved full hematopoietic recovery following the
             transplant.

          -  Participants with grade 3/4 cardiac disease or any serious, concomitant, medical
             condition.

          -  Participants with a history of non-compliance to medical regimens or who were
             considered potentially unreliable.

        Other protocol-defined inclusion/exclusion criteria may apply.