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

September 15, 2014 updated by: DR RENATO BASSAN, Northern Italy Leukemia Group

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

Completed

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:

  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

Enrollment (Actual)

182

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy, 24128
        • USC Ematologia Ospedali Riuniti di Bergamo
    • (bz)
      • Bolzano, (bz), Italy
        • Divisione di Ematologia e TMO, Ospedale San Maurizio
    • (ca)
      • Cagliari, (ca), Italy
        • Ematologia e centro TMO - Ospedale Armando Businco
    • (cn)
      • Cuneo, (cn), Italy
        • S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
    • (ve)
      • Noale, (ve), Italy
        • Onco-Ematologia - Ospedale Civile
    • AL
      • Alessandria, AL, Italy
        • Dipartimento di Ematologia e Medicina Trasfusionale - Azienda Osp. Nazionale Santi Antonio e Biagio e Cesare Arrigo
    • BG
      • Bergamo, BG, Italy
        • USC Ematologia Ospedali Riuniti di Bergamo
    • BS
      • Brescia, BS, Italy, 25123
        • Divisione Ematologia Spedali Civili
    • FI
      • Firenze, FI, Italy
        • Ematologia - AOU Careggi
    • MI
      • Milano, MI, Italy
        • Ematologia e TMO - Ospedale San Raffaele
      • Monza, MI, Italy
        • Ematologia - TMO - Ospedale San Gerardo
    • VI
      • Vicenza, VI, Italy, 36100
        • Ematologia Ospedale San Bortolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Northern Italy Leukemia Group

Investigators

  • Principal Investigator: Renato Bassan, MD, USC Ematologia Ospedali Riuniti di Bergamo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

February 2, 2011

First Submitted That Met QC Criteria

February 3, 2011

First Posted (Estimate)

February 4, 2011

Study Record Updates

Last Update Posted (Estimate)

September 16, 2014

Last Update Submitted That Met QC Criteria

September 15, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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