Clinical Trial: Chemotherapy Plus Rituximab Combination for Adult Lymphoblastic Leukemia (B-ALL) and Burkitt's Non-Hodgkin Lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Multicentre Study to Optimize Therapy of Burkitt's Leukemia (B-ALL) and Non-Hodgkin Lymphoma

Brief Summary:

The study was set up to assess the efficacy and tolerability of a chemotherapy-immunotherapy combination programme originally introduced by GMALL (the German cooperative group for adult acute lymphoblastic leukemia)in 2002, to improve remission rate, overall and disease-free survival rates of adult patients with Burkitt's leukemia and lymphoma.

The therapy includes a maximum of six chemotherapy courses (two with high doses of methotrexate and cytarabine) plus anti-CD20 antibody (Rituximab, up to 8 total doses), supplemented by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy.


Detailed Summary:

Cycle A1: prednisone-cyclophosphamide pre-phase (5 days), Rituximab on day 0, chemotherapy on days 1-5 (dexamethasone, iphosphamide, vincristine, high-dose methotrexate, triple intrathecal therapy).

Cycle B1: Rituximab on day 0, chemotherapy on days 1-5 (dexamethasone, vincristine, cyclophosphamide, high-dose methotrexate, adriamycin, triple intrathecal therapy) Cycle C1: Rituximab on day 0, chemotherapy on days 1-5 (dexamethasone, vindesine, high-dose methotrexate, etoposide, high-dose cytarabine).

Cycle A2: like cycle A1, without pre-phase. Cycle B2: like cycle B1. Cycle C2: like cycle C1. Cycle C2 is followed by two additional Rituximab injections.

Notes:

  1. patients with stage I-II disease without mediastinal tumor or extranodal involvement receive only the first 4 cycles (A1 to A2).
  2. patients aged >55 years do not receive cycles C (sequence: A1, B1, A2, B2, A3, B3 or A1, B1, A2, B2 if limited stage, with reduced-dose methotrexate).

Sponsor: Northern Italy Leukemia Group

Current Primary Outcome: Overall survival [ Time Frame: 5 years ]

Percentage of patients alive without disease at 5 years from date of diagnosis


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disease free survival [ Time Frame: 5 years ]
    Percentage of patients alive without disease at 5 years from date of remission
  • Cumulative incidence of relapse [ Time Frame: 5 years ]
    Percentage of relapsed patients at 5 years from date of remission
  • Complete remission rate [ Time Frame: Up to 24 weeks ]
    Percentage of patients achieving complete remission after the first two treatment cycles (defining the early response rate), and then confirmed to remain in complete remission at end of the six chemotherapy blocks. Re-staging procedures include physical examination, blood counts and biochemistry, bone marrow examination , and instrumental tests as appropriate (ultrasound scans, computed tomography, nuclear magnetic resonance, positron emission tomography)depending on clinical presentation of individual subjects.
  • Toxicity [ Time Frame: 1 year ]
    Percentage of patients who develop early and late therapy-related toxic side effects (including death in complete remision). Toxicity is defined according to the Common Toxicity Criteria scale (NCI), graded I-IV and referring to both hematological and extrahematologic toxicity. Early toxicity is registered during the first two chemotherapy cycles, and late toxicity following completion of therapy and up to 1 year from diagnosis.


Original Secondary Outcome: Same as current

Information By: Northern Italy Leukemia Group

Dates:
Date Received: February 2, 2011
Date Started: November 2002
Date Completion:
Last Updated: September 15, 2014
Last Verified: September 2014