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

Sponsor

Northern Italy Leukemia Group (Other)

Overall Status

Completed

CT.gov ID

NCT01290120

Collaborator

(none)

182

Enrollment

Locations

139

Duration (Months)

15.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burkitt Lymphoma B-ALL	Drug: Chemotherapy-Rituximab combination	Phase 2

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:

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 Design

Study Type:

Interventional

Actual Enrollment :

182 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2002

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Outcome Measures

Primary Outcome Measures

Overall survival [5 years]
Percentage of patients alive without disease at 5 years from date of diagnosis

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Divisione di Ematologia e TMO, Ospedale San Maurizio	Bolzano	(bz)	Italy
2	Ematologia e centro TMO - Ospedale Armando Businco	Cagliari	(ca)	Italy
3	S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle	Cuneo	(cn)	Italy
4	Onco-Ematologia - Ospedale Civile	Noale	(ve)	Italy
5	Dipartimento di Ematologia e Medicina Trasfusionale - Azienda Osp. Nazionale Santi Antonio e Biagio e Cesare Arrigo	Alessandria	AL	Italy
6	USC Ematologia Ospedali Riuniti di Bergamo	Bergamo	BG	Italy
7	Divisione Ematologia Spedali Civili	Brescia	BS	Italy	25123
8	Ematologia - AOU Careggi	Firenze	FI	Italy
9	Ematologia e TMO - Ospedale San Raffaele	Milano	MI	Italy
10	Ematologia - TMO - Ospedale San Gerardo	Monza	MI	Italy
11	Ematologia Ospedale San Bortolo	Vicenza	VI	Italy	36100
12	USC Ematologia Ospedali Riuniti di Bergamo	Bergamo		Italy	24128