Chemotherapy Plus Rituximab Combination for Adult Lymphoblastic Leukemia (B-ALL) and Burkitt's Non-Hodgkin Lymphoma
Primary Purpose
Burkitt Lymphoma, B-ALL
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Chemotherapy-Rituximab combination
Sponsored by
About this trial
This is an interventional treatment trial for Burkitt Lymphoma focused on measuring Burkitt Lymphoma, B-ALL, Adult patients
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
Sites / Locations
- Divisione di Ematologia e TMO, Ospedale San Maurizio
- Ematologia e centro TMO - Ospedale Armando Businco
- S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
- Onco-Ematologia - Ospedale Civile
- Dipartimento di Ematologia e Medicina Trasfusionale - Azienda Osp. Nazionale Santi Antonio e Biagio e Cesare Arrigo
- USC Ematologia Ospedali Riuniti di Bergamo
- Divisione Ematologia Spedali Civili
- Ematologia - AOU Careggi
- Ematologia e TMO - Ospedale San Raffaele
- Ematologia - TMO - Ospedale San Gerardo
- Ematologia Ospedale San Bortolo
- USC Ematologia Ospedali Riuniti di Bergamo
Outcomes
Primary Outcome Measures
Overall survival
Percentage of patients alive without disease at 5 years from date of diagnosis
Secondary Outcome Measures
Disease free survival
Percentage of patients alive without disease at 5 years from date of remission
Cumulative incidence of relapse
Percentage of relapsed patients at 5 years from date of remission
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.
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.
Full Information
NCT ID
NCT01290120
First Posted
February 2, 2011
Last Updated
September 15, 2014
Sponsor
Northern Italy Leukemia Group
1. Study Identification
Unique Protocol Identification Number
NCT01290120
Brief Title
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
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern Italy Leukemia Group
4. Oversight
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burkitt Lymphoma, B-ALL
Keywords
Burkitt Lymphoma, B-ALL, Adult patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Chemotherapy-Rituximab combination
Other Intervention Name(s)
Mabthera, Rituxan, Endoxan, Aracytin, Doxorubicin, Vepesid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival
Description
Percentage of patients alive without disease at 5 years from date of diagnosis
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Disease free survival
Description
Percentage of patients alive without disease at 5 years from date of remission
Time Frame
5 years
Title
Cumulative incidence of relapse
Description
Percentage of relapsed patients at 5 years from date of remission
Time Frame
5 years
Title
Complete remission rate
Description
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.
Time Frame
Up to 24 weeks
Title
Toxicity
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato Bassan, MD
Organizational Affiliation
USC Ematologia Ospedali Riuniti di Bergamo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Divisione di Ematologia e TMO, Ospedale San Maurizio
City
Bolzano
State/Province
(bz)
Country
Italy
Facility Name
Ematologia e centro TMO - Ospedale Armando Businco
City
Cagliari
State/Province
(ca)
Country
Italy
Facility Name
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
City
Cuneo
State/Province
(cn)
Country
Italy
Facility Name
Onco-Ematologia - Ospedale Civile
City
Noale
State/Province
(ve)
Country
Italy
Facility Name
Dipartimento di Ematologia e Medicina Trasfusionale - Azienda Osp. Nazionale Santi Antonio e Biagio e Cesare Arrigo
City
Alessandria
State/Province
AL
Country
Italy
Facility Name
USC Ematologia Ospedali Riuniti di Bergamo
City
Bergamo
State/Province
BG
Country
Italy
Facility Name
Divisione Ematologia Spedali Civili
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy
Facility Name
Ematologia - AOU Careggi
City
Firenze
State/Province
FI
Country
Italy
Facility Name
Ematologia e TMO - Ospedale San Raffaele
City
Milano
State/Province
MI
Country
Italy
Facility Name
Ematologia - TMO - Ospedale San Gerardo
City
Monza
State/Province
MI
Country
Italy
Facility Name
Ematologia Ospedale San Bortolo
City
Vicenza
State/Province
VI
ZIP/Postal Code
36100
Country
Italy
Facility Name
USC Ematologia Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
23753030
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.
Results Reference
derived
Learn more about this trial
Chemotherapy Plus Rituximab Combination for Adult Lymphoblastic Leukemia (B-ALL) and Burkitt's Non-Hodgkin Lymphoma
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