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Trial record 2 of 549 for:    non-Hodgkin's lymphoma AND Burkitt lymphoma

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

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ClinicalTrials.gov Identifier: NCT01290120
Recruitment Status : Completed
First Posted : February 4, 2011
Last Update Posted : September 16, 2014
Sponsor:
Information provided by (Responsible Party):
DR RENATO BASSAN, 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.


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:

  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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
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 : November 2002
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014



Intervention Details:
  • 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.
    Other Names:
    • Mabthera
    • Rituxan
    • Endoxan
    • Aracytin
    • Doxorubicin
    • Vepesid


Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    Percentage of patients alive without disease at 5 years from date of diagnosis


Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: 5 years ]
    Percentage of patients alive without disease at 5 years from date of remission

  2. Cumulative incidence of relapse [ Time Frame: 5 years ]
    Percentage of relapsed patients at 5 years from date of remission

  3. 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.

  4. 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.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290120


Locations
Italy
Divisione di Ematologia e TMO, Ospedale San Maurizio
Bolzano, (bz), Italy
Ematologia e centro TMO - Ospedale Armando Businco
Cagliari, (ca), Italy
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
Cuneo, (cn), Italy
Onco-Ematologia - Ospedale Civile
Noale, (ve), 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
Divisione Ematologia Spedali Civili
Brescia, BS, Italy, 25123
Ematologia - AOU Careggi
Firenze, FI, Italy
Ematologia e TMO - Ospedale San Raffaele
Milano, MI, Italy
Ematologia - TMO - Ospedale San Gerardo
Monza, MI, Italy
Ematologia Ospedale San Bortolo
Vicenza, VI, Italy, 36100
USC Ematologia Ospedali Riuniti di Bergamo
Bergamo, Italy, 24128
Sponsors and Collaborators
Northern Italy Leukemia Group
Investigators
Principal Investigator: Renato Bassan, MD USC Ematologia Ospedali Riuniti di Bergamo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: DR RENATO BASSAN, MD, Northern Italy Leukemia Group
ClinicalTrials.gov Identifier: NCT01290120     History of Changes
Other Study ID Numbers: NILG 2009-012950-19
First Posted: February 4, 2011    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014

Keywords provided by DR RENATO BASSAN, Northern Italy Leukemia Group:
Burkitt Lymphoma
B-ALL
Adult patients

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Burkitt Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents