Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: asparaginase; daunorubicin hydrochloride; etoposide; idarubicin; imatinib mesylate; mercaptopurine; methotrexate; methylprednisolone; mitoxantrone hydrochloride; prednisone; vincristine sulfate; allogeneic hematopoietic stem cell transplantation; autologous hematopoietic stem cell transplantation; peripheral blood stem cell transplantation; radiation therapy
Intervention MeSH terms: Prednisone; Methylprednisolone; Methotrexate; Etoposide; Vincristine; Imatinib Mesylate; Daunorubicin; Asparaginase; Mitoxantrone; Mercaptopurine; Idarubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 470.0
Sex: All
Minimum age: 15 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: B-cell adult acute lymphoblastic leukemia; T-cell adult acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia; L1 adult acute lymphoblastic leukemia; L2 adult acute lymphoblastic leukemia; TdT positive adult acute lymphoblastic leukemia

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
      cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may
      stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A
      peripheral stem cell transplant may be able to replace blood-forming cells that were
      destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may
      help the patient's bone marrow make stem cells, red blood cells, white blood cells, and
      platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral
      stem cell transplant may be an effective treatment for acute lymphoblastic leukemia.

      Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL
      patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will
      be implemented in patients pertaining to this category.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of acute lymphoblastic leukemia (ALL) meeting the following criteria:

               -  Negative myeloperoxidase stain

               -  Phenotype T (T-ALL) or B (B-ALL)

               -  No mature B-ALL (FAB L3, serum immunoglobulin-positive, terminal deoxynucleotidyl
                  transferase-negative)

        PATIENT CHARACTERISTICS:

          -  Creatinine ≤ 2.5 mg/dL (after adequate hydration)

          -  SGOT and SGPT ≤ 3 times upper limit of normal

          -  LVEF ≥ 50%

          -  No severe psychiatric disorders

          -  No other concurrent malignant disease

          -  No presence of documented infections not responding to antibiotic and/or antifungal
             therapy

          -  Not pregnant

        PRIOR CONCURRENT THERAPY:

          -  No prior steroids

          -  No prior antiblastic chemotherapy

          -  No other concurrent chemotherapy or radiotherapy