Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional

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. Giving more than one
      drug (combination chemotherapy) together with steroid therapy may kill more cancer cells.

      PURPOSE: This clinical trial is studying the side effects of combination chemotherapy in
      treating young adult patients with acute lymphoblastic leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the feasibility of combination chemotherapy in young adult patients with
           acute lymphoid leukemia.

        -  To determine the complete response rate at the end of induction therapy in these
           patients.

        -  To determine the overall survival of patients treated with these regimens.

        -  To determine the disease-free survival of patients treated with these regimens.

        -  To determine the event-free survival of patients treated with these regimens.

        -  To determine toxicity of these regimens.

        -  To determine compliance related to dose intensity.

      OUTLINE:

        -  Steroids prephase therapy: All patients receive steroids (i.e., prednisone or
           methylprednisolone) and methotrexate.

        -  Induction therapy (induction Ia followed by Ib): Patients receive induction Ia
           comprising vincristine, daunorubicin hydrochloride, asparaginase, and prednisone. They
           then receive induction Ib comprising cyclophosphamide, mercaptopurine, and cytarabine.
           Patients who achieve hematological remission proceed to consolidation therapy.

        -  Consolidation therapy: Patients receive consolidation therapy according to risk group.

             -  Standard-risk patients: Patients receive high-dose methotrexate and mercaptopurine.

             -  High-risk patients: Patients receive consolidation therapy in 3 steps.

                  -  Step 1: Patients receive dexamethasone, vincristine, methotrexate, cytarabine,
                     and asparaginase.

                  -  Step 2: Patients receive dexamethasone, vindesine, methotrexate, ifosfamide,
                     asparaginase, and daunorubicin hydrochloride.

                  -  Step 3: Patients receive dexamethasone, cytarabine, and asparaginase. After
                     completion of consolidation therapy, patients proceed to reinduction therapy.

        -  Reinduction therapy (reinduction IIa followed by IIb): Patients receive reinduction IIa
           comprising vincristine, doxorubicin hydrochloride, asparaginase, and dexamethasone.
           Patients then receive reinduction IIb comprising cyclophosphamide, thioguanine, and
           cytarabine.
    

Intervention name(s): asparaginase; cyclophosphamide; cytarabine; daunorubicin hydrochloride; dexamethasone; doxorubicin hydrochloride; ifosfamide; mercaptopurine; methotrexate; methylprednisolone; prednisone; thioguanine; vincristine sulfate; vindesine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Cytarabine; Dexamethasone; Prednisone; Methylprednisolone; Cyclophosphamide; Ifosfamide; Doxorubicin; Liposomal doxorubicin; Methotrexate; Vincristine; Daunorubicin; Asparaginase; Mercaptopurine; Thioguanine; Vindesine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-cell adult acute lymphoblastic leukemia; recurrent adult acute lymphoblastic leukemia; T-cell adult acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia