Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Treatments: 6-Mercaptopurine; Asparaginase; Daunorubicin; Etoposide; Idarubicin; Imatinib Mesylate; Mercaptopurine; Methotrexate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Mitoxantrone; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Vincristine

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