Chemotherapy Plus Rituximab Combination for Adult Lymphoblastic Leukemia (B-ALL) and Burkitt's Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT01290120|
Recruitment Status : Completed
First Posted : February 4, 2011
Last Update Posted : September 16, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Burkitt Lymphoma B-ALL||Drug: Chemotherapy-Rituximab combination||Phase 2|
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.
- patients with stage I-II disease without mediastinal tumor or extranodal involvement receive only the first 4 cycles (A1 to A2).
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||182 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicentre Study to Optimize Therapy of Burkitt's Leukemia (B-ALL) and Non-Hodgkin Lymphoma|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Drug: Chemotherapy-Rituximab combination
- Overall survival [ Time Frame: 5 years ]Percentage of patients alive without disease at 5 years from date of diagnosis
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290120
|Divisione di Ematologia e TMO, Ospedale San Maurizio|
|Bolzano, (bz), Italy|
|Ematologia e centro TMO - Ospedale Armando Businco|
|Cagliari, (ca), Italy|
|S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle|
|Cuneo, (cn), Italy|
|Onco-Ematologia - Ospedale Civile|
|Noale, (ve), Italy|
|Dipartimento di Ematologia e Medicina Trasfusionale - Azienda Osp. Nazionale Santi Antonio e Biagio e Cesare Arrigo|
|Alessandria, AL, Italy|
|USC Ematologia Ospedali Riuniti di Bergamo|
|Bergamo, BG, Italy|
|Divisione Ematologia Spedali Civili|
|Brescia, BS, Italy, 25123|
|Ematologia - AOU Careggi|
|Firenze, FI, Italy|
|Ematologia e TMO - Ospedale San Raffaele|
|Milano, MI, Italy|
|Ematologia - TMO - Ospedale San Gerardo|
|Monza, MI, Italy|
|Ematologia Ospedale San Bortolo|
|Vicenza, VI, Italy, 36100|
|USC Ematologia Ospedali Riuniti di Bergamo|
|Bergamo, Italy, 24128|
|Principal Investigator:||Renato Bassan, MD||USC Ematologia Ospedali Riuniti di Bergamo|