Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to evaluate the safety and efficacy of Rituximab combined
      with chemotherapy in CD20+ adult acute lymphoblastic leukemia.
    

Detailed description: 
      Acute lymphoblastic leukemia (ALL) is a group of biologically heterogeneous diseases with
      diverse prognosis. Novel strategies for adult ALL have approached a CR rate of over 80%,
      which is similar to pediatric ALL. But the long term survival of adult ALL is only 30%-40%,
      much lower than pediatric patients.

      In our trial, all the patients will first receive Vincristine 1.4mg/m2, max 2mg IV days
      1,8,15,22, Daunorubicin 45mg/m2 IV days 1-3,Cyclophosphamide 750mg/m2 IV day 1 and prednisone
      40-60mg/m2,by mouth days 1-14 (VDCP)regimen as initial induction therapy. If patients achieve
      complete remission after induction, they will be enrolled in our study for further
      consolidation and maintenance. If the tumor cells in bone marrow remain 5% to 20% after
      induction, the patients will receive VDCLP(VDCP+L-asparaginase 6000IU/m2 IV days5,7,9,11,13)
      and be enrolled until complete remission.

      Rituximab is the main experimental intervention in our study.The consolidation regimen is
      HyperCVAD/MA or R-HyperCVAD/MA for totally 8 courses. The maintenance regimen includes
      6-Mercaptopurine+Methotrexate for 24 months, Vincristine+Prednisone for the first 12 months,
      L-asparaginase in month 3 and 9 with or without Rituximab in month 6 and 12.
    

Intervention name(s): Cyclophosphamide; Doxorubicin; Vincristine; Dexamethasone; Cytarabine; Methotrexate; Rituximab; 6-Mercaptopurine; Prednisone; L-asparaginase
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2)(odd courses).; 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses).; Consolidation:1.4 mg/m2 (max 2mg) IV on day 4 and day 11 (odd courses). Maintenance:1.4mg/m2(max 2mg) IV monthly from 1st to 12th month.; 40mg IV or by mouth (P.O.) daily days 1-4 and days 11-14(odd courses); 2g/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses).; Consolidation:1000 mg/m2 IV over 24 hours on day 1 (even courses). Maintenance:25mg/m2 weekly for 24 months.; Consolidation:375 mg/m2 IV day 1 for the odd courses of therapy (total 4 times).
Maintenance:375 mg/m2 IV in 6th month and 12th month.; Maintenance:60mg/m2 daily for 24 months.; Maintenance:40mg/m2 from days 1-7 monthly from 1st to 12th month.; Maintenance:6000IU/m2 IV on days 1,3,5 of the 3rd and 9th month.
Intervention MeSH terms: Cytarabine; Dexamethasone; Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Methotrexate; Vincristine; Asparaginase; Mercaptopurine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rituximab; HyperCVAD