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

Phase 2

Completed

• Conditions: Burkitt Lymphoma; B-ALL

• Registration Number: NCT01290120
• Lead Sponsor: Northern Italy Leukemia Group

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).

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-04
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-15
• Last Update Posted: 2014-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years	Percentage of patients alive without disease at 5 years from date of diagnosis

Secondary Outcome Measures

Name	Time	Method
Disease free survival	5 years	Percentage of patients alive without disease at 5 years from date of remission
Cumulative incidence of relapse	5 years	Percentage of relapsed patients at 5 years from date of remission
Complete remission rate	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	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.

Trial Locations

Locations (11)

Onco-Ematologia - Ospedale Civile; 🇮🇹 Noale, (ve), Italy

Ematologia e TMO - Ospedale San Raffaele; 🇮🇹 Milano, MI, Italy

Ematologia Ospedale San Bortolo; 🇮🇹 Vicenza, VI, Italy

USC Ematologia Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy

Ematologia - AOU Careggi; 🇮🇹 Firenze, FI, Italy

S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle; 🇮🇹 Cuneo, (cn), Italy

Dipartimento di Ematologia e Medicina Trasfusionale - Azienda Osp. Nazionale Santi Antonio e Biagio e Cesare Arrigo; 🇮🇹 Alessandria, AL, Italy

Ematologia - TMO - Ospedale San Gerardo; 🇮🇹 Monza, MI, Italy

Divisione di Ematologia e TMO, Ospedale San Maurizio; 🇮🇹 Bolzano, (bz), Italy

Ematologia e centro TMO - Ospedale Armando Businco; 🇮🇹 Cagliari, (ca), Italy

Divisione Ematologia Spedali Civili; 🇮🇹 Brescia, BS, Italy