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

Burkitt Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290120
• Other study ID #: NILG 2009-012950-19
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2011
• Last updated: September 15, 2014
• Start date: November 2002
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: Northern Italy Leukemia Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-ALL
• Burkitt Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Chemotherapy-Rituximab combination
Short cycles of high-dose and conventional chemotherapy in combination with rituximab, followed by local radiotherapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. Used drugs are rituximab,cyclophosphamide, prednisone, dexamethasone, vincristine, methotrexate, iphosphamide, teniposide, etoposide, dexamethasone, cytarabine,adriamycin, vincristine, vindesine.

Locations

Country	Name	City	State
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	USC Ematologia Ospedali Riuniti di Bergamo	Bergamo
Italy	Divisione di Ematologia e TMO, Ospedale San Maurizio	Bolzano	(bz)
Italy	Divisione Ematologia Spedali Civili	Brescia	BS
Italy	Ematologia e centro TMO - Ospedale Armando Businco	Cagliari	(ca)
Italy	S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle	Cuneo	(cn)
Italy	Ematologia - AOU Careggi	Firenze	FI
Italy	Ematologia e TMO - Ospedale San Raffaele	Milano	MI
Italy	Ematologia - TMO - Ospedale San Gerardo	Monza	MI
Italy	Onco-Ematologia - Ospedale Civile	Noale	(ve)
Italy	Ematologia Ospedale San Bortolo	Vicenza	VI

Sponsors (1)

Lead Sponsor	Collaborator
Northern Italy Leukemia Group

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Percentage of patients alive without disease at 5 years from date of diagnosis	5 years	No
Secondary	Disease free survival	Percentage of patients alive without disease at 5 years from date of remission	5 years	No
Secondary	Cumulative incidence of relapse	Percentage of relapsed patients at 5 years from date of remission	5 years	No
Secondary	Complete remission rate	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.	Up to 24 weeks	No
Secondary	Toxicity	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.	1 year	Yes