- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01290120
Chemotherapy Plus Rituximab Combination for Adult Lymphoblastic Leukemia (B-ALL) and Burkitt's Non-Hodgkin Lymphoma
Multicentre Study to Optimize Therapy of Burkitt's Leukemia (B-ALL) and Non-Hodgkin Lymphoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Bergamo, Italy, 24128
- USC Ematologia Ospedali Riuniti di Bergamo
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-
(bz)
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Bolzano, (bz), Italy
- Divisione di Ematologia e TMO, Ospedale San Maurizio
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(ca)
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Cagliari, (ca), Italy
- Ematologia e centro TMO - Ospedale Armando Businco
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(cn)
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Cuneo, (cn), Italy
- S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
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(ve)
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Noale, (ve), Italy
- Onco-Ematologia - Ospedale Civile
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AL
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Alessandria, AL, Italy
- Dipartimento di Ematologia e Medicina Trasfusionale - Azienda Osp. Nazionale Santi Antonio e Biagio e Cesare Arrigo
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BG
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Bergamo, BG, Italy
- USC Ematologia Ospedali Riuniti di Bergamo
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BS
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Brescia, BS, Italy, 25123
- Divisione Ematologia Spedali Civili
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FI
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Firenze, FI, Italy
- Ematologia - AOU Careggi
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MI
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Milano, MI, Italy
- Ematologia e TMO - Ospedale San Raffaele
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Monza, MI, Italy
- Ematologia - TMO - Ospedale San Gerardo
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VI
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Vicenza, VI, Italy, 36100
- Ematologia Ospedale San Bortolo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 5 years
|
Percentage of patients alive without disease at 5 years from date of diagnosis
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease free survival
Time Frame: 5 years
|
Percentage of patients alive without disease at 5 years from date of remission
|
5 years
|
Cumulative incidence of relapse
Time Frame: 5 years
|
Percentage of relapsed patients at 5 years from date of remission
|
5 years
|
Complete remission rate
Time Frame: 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.
|
Up to 24 weeks
|
Toxicity
Time Frame: 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.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Renato Bassan, MD, USC Ematologia Ospedali Riuniti di Bergamo
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- DNA Virus Infections
- Tumor Virus Infections
- Epstein-Barr Virus Infections
- Herpesviridae Infections
- Lymphoma, B-Cell
- Lymphoma
- Lymphoma, Non-Hodgkin
- Burkitt Lymphoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Antibiotics, Antineoplastic
- Rituximab
- Doxorubicin
Other Study ID Numbers
- NILG 2009-012950-19
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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