CLAG Gleevec in Relapsed or Refractory Acute Myeloid Leukemia (AML)
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid, Acute
Intervention: CLAG Regimen; Gleevec®
Intervention description: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine.; Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).
Intervention MeSH terms: Cytarabine; Imatinib Mesylate; Cladribine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: relapsed; refractory; acute; myeloid; AML; CML; blast crisis

Summary:

      The purpose of the study is to find out what effects (good and bad) Gleevec® (Imatinib
      mesylate) combined with chemotherapy has on participants and their acute myeloid leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and Women of all ethnic groups whose age is ≥ 18 years old.

          -  Diagnosis of AML or CML blast crisis, according to World Health Organization (WHO)
             criteria, except acute promyelocytic leukemia AML-M3 French-American-British (FAB)
             subgroup. A documentation of relapse is required by a bone marrow/aspirate within 4
             weeks of registration.

          -  Refractory or Relapsed AML. Refractory AML is defined as failure to achieve CR after 2
             cycles of induction chemotherapy or persistent (>40%) bone marrow blasts after one
             cycle of chemotherapy induction.

          -  Relapsed AML is defined as any evidence of disease recurrence after achieving complete
             response (CR) (more than 5% myeloblasts). Early relapse is defined as that occurring
             within 12 months and late relapse is defines as that occurring after 12 months.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Patients must sign a written informed consent.

          -  Females of childbearing potential (FOCP) must not be pregnant or actively nursing a
             child. They must have a negative pregnancy test 7 days before initiation of study drug
             administration

          -  Postmenopausal women must be amenorrheic for at least 12 months to be considered of
             non-childbearing potential.

          -  Male and females of reproductive potential must agree to employ an effective barrier
             method of birth control throughout the duration of the trial and for 3 months
             following study medication discontinuation.

          -  Prior allogeneic or autologous stem cell transplantation is allowed.

        Exclusion Criteria:

          -  Abnormal Kidney Functions: creatinine ≥2.5 mg/dL.

          -  Abnormal Liver Functions: Bilirubin more 3 mg/dL, transaminases (AST/ALT) more than
             2.5 times the institutional upper limits of normal (IULN).

          -  Systemic active infection, unless controlled on active therapy.

          -  Patients with Grade III/IV cardiac problems as defined by the New York Heart
             Association (NYHA) Criteria ( i.e., congestive heart failure, myocardial infarction
             within 6 months of the study), or ejection fraction (EF)< 30%.

          -  Patient has known chronic liver disease (i.e., chronic active hepatitis, hepatitis B,
             hepatitis C, and cirrhosis).

          -  Patient has known diagnosis of human immunodeficiency virus (HIV) infection.

          -  History of other malignancy, except non-melanotic skin cancers or no disease
             recurrence/progression for more than 2 years.

          -  Patients that have received investigational agents within 1 month of study entry.

          -  History of allergic reaction attributed to compounds of similar chemical or biologic
             composition to Gleevec or any component of the CLAG regimen

          -  Prior therapy with CLAG chemotherapy regimen

          -  Any adverse event attributable to previous chemotherapy regimen must be resolved to
             grade 1 or less at time of registration.