Clinical trial NCT01290120: Chemotherapy Plus Rituximab Combination for Adult Lymphoblastic Leukemia (B-ALL) and Burkitt's Non-Hodgkin Lymphoma
Official title: Multicentre Study to Optimize Therapy of Burkitt's Leukemia (B-ALL) and Non-Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Burkitt Lymphoma
B-ALL
Keywords: Burkitt Lymphoma
B-ALL
Adult patients
Lead sponsor: Northern Italy Leukemia Group
Sponsor class: OTHER
First posted: 2011-02-04
Enrollment: 182
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 description: 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).

Eligibility criteria: Inclusion Criteria:

* Burkitt's leukemia or lymphoma (new diagnosis)
* Written informed consent
* Age \> 15 years

Exclusion Criteria:

* pre-treated Burkitt's leukemia or lymphoma
* psychiatric disorders
* active second malignancy
* pregnancy
* absence of patient's written informed consent
* participation in other studies that interfere with the study therapy

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Disease free survival
timeFrame: 5 years
measure: Cumulative incidence of relapse
timeFrame: 5 years
measure: Complete remission rate
timeFrame: Up to 24 weeks
measure: Toxicity
timeFrame: 1 year
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: Divisione di Ematologia e TMO, Ospedale San Maurizio
state: (bz)
city: Cagliari
country: Italy
facility: Ematologia e centro TMO - Ospedale Armando Businco
state: (ca)
city: Cuneo
country: Italy
facility: S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
state: (cn)
city: Noale
country: Italy
facility: Onco-Ematologia - Ospedale Civile
state: (ve)
city: Alessandria
country: Italy
facility: Dipartimento di Ematologia e Medicina Trasfusionale - Azienda Osp. Nazionale Santi Antonio e Biagio e Cesare Arrigo
state: AL
city: Bergamo
country: Italy
facility: USC Ematologia Ospedali Riuniti di Bergamo
state: BG
city: Brescia
country: Italy
facility: Divisione Ematologia Spedali Civili
state: BS
city: Firenze
country: Italy
facility: Ematologia - AOU Careggi
state: FI
city: Milano
country: Italy
facility: Ematologia e TMO - Ospedale San Raffaele
state: MI
city: Monza
country: Italy
facility: Ematologia - TMO - Ospedale San Gerardo
state: MI
city: Vicenza
country: Italy
facility: Ematologia Ospedale San Bortolo
state: VI
city: Bergamo
country: Italy
facility: USC Ematologia Ospedali Riuniti di Bergamo
Study officials:
affiliation: USC Ematologia Ospedali Riuniti di Bergamo
name: Renato Bassan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Intermesoli T, Rambaldi A, Rossi G, Delaini F, Romani C, Pogliani EM, Pagani C, Angelucci E, Terruzzi E, Levis A, Cassibba V, Mattei D, Gianfaldoni G, Scattolin AM, Di Bona E, Oldani E, Parolini M, Gokbuget N, Bassan R. High cure rates in Burkitt lymphoma and leukemia: a Northern Italy Leukemia Group study of the German short intensive rituximab-chemotherapy program. Haematologica. 2013 Nov;98(11):1718-25. doi: 10.3324/haematol.2013.086827. Epub 2013 Jun 10.