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Burkitt LymphomaPhase 2NCT01290120

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

A Phase 2 study testing Chemotherapy-Rituximab combination in people with Burkitt Lymphoma and B-ALL, run by Northern Italy Leukemia Group at 12 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Burkitt Lymphoma, B-ALL
What is being tested?
Chemotherapy-Rituximab combination
How many people
182 participants
Where
12 sitesItaly
Study dates
Nov 2002to Jun 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Burkitt's leukemia or lymphoma (new diagnosis)
  • Written informed consent
  • Age > 15 years

Who cannot join

  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Italy12 sites

  • Dipartimento di Ematologia e Medicina Trasfusionale - Azienda Osp. Nazionale Santi Antonio e Biagio e Cesare Arrigo

    Alessandria, AL

  • USC Ematologia Ospedali Riuniti di Bergamo

    Bergamo, BG

  • USC Ematologia Ospedali Riuniti di Bergamo

    Bergamo, 24128

  • Divisione di Ematologia e TMO, Ospedale San Maurizio

    Bolzano, (bz)

  • Divisione Ematologia Spedali Civili

    Brescia, BS, 25123

  • Ematologia e centro TMO - Ospedale Armando Businco

    Cagliari, (ca)

  • S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle

    Cuneo, (cn)

  • Ematologia - AOU Careggi

    Florence, FI

  • Ematologia e TMO - Ospedale San Raffaele

    Milan, MI

  • Ematologia - TMO - Ospedale San Gerardo

    Monza, MI

  • Onco-Ematologia - Ospedale Civile

    Noale, (ve)

  • Ematologia Ospedale San Bortolo

    Vicenza, VI, 36100

Other trials in Italy

About this study

Official title: 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.

Read the 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).
Being tested
Chemotherapy-Rituximab combination
Keywords
Burkitt Lymphoma, B-ALL, Adult patients
Medical subject headings
Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chemotherapy-Rituximab combinationDrug

    Also called Mabthera, Rituxan, Endoxan, Aracytin

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Percentage of patients alive without disease at 5 years from date of diagnosis

    Measured: 5 years

Secondary outcomes (4)

  1. Disease free survival

    Percentage of patients alive without disease at 5 years from date of remission

    Measured: 5 years

  2. Cumulative incidence of relapse

    Percentage of relapsed patients at 5 years from date of remission

    Measured: 5 years

  3. 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.

    Measured: Up to 24 weeks

  4. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2011 (estimated)
  2. Study startNov 2002
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01290120
Sponsor's protocol ID
NILG 2009-012950-19
Status last verified
Sep 2014
First submitted
2 Feb 2011
Last updated
16 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23753030

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chemotherapy-Rituximab combination in people with Burkitt Lymphoma and B-ALL, run by Northern Italy Leukemia Group at 12 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01290120, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2014.

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