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

NCT01290120 | Completed Phase 2

• 1 other identifier: NILG 2009-012950-19
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 12

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.

Conditions

Burkitt Lymphoma; B-ALL

Keywords

Burkitt Lymphoma; B-ALL; Adult patients

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

  5 years

Secondary Outcomes (4)

• Disease free survival

  5 years

• Cumulative incidence of relapse

  5 years

• Complete remission rate

  Up to 24 weeks

• Toxicity

  1 year

Interventions

Chemotherapy-Rituximab combination DRUG

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.

Also known as: Mabthera, Rituxan, Endoxan, Aracytin, Doxorubicin, Vepesid

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Italy Leukemia Group: lead

Study Sites (12)

Divisione di Ematologia e TMO, Ospedale San Maurizio

Bolzano, (bz), Italy

Location

Ematologia e centro TMO - Ospedale Armando Businco

Cagliari, (ca), Italy

Location

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

Cuneo, (cn), Italy

Location

Onco-Ematologia - Ospedale Civile

Noale, (ve), Italy

Location

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

Alessandria, AL, Italy

Location

USC Ematologia Ospedali Riuniti di Bergamo

Bergamo, BG, Italy

Location

Divisione Ematologia Spedali Civili

Brescia, BS, 25123, Italy

Location

Ematologia - AOU Careggi

Florence, FI, Italy

Location

Ematologia e TMO - Ospedale San Raffaele

Milan, MI, Italy

Location

Ematologia - TMO - Ospedale San Gerardo

Monza, MI, Italy

Location

Ematologia Ospedale San Bortolo

Vicenza, VI, 36100, Italy

Location

USC Ematologia Ospedali Riuniti di Bergamo

Bergamo, 24128, Italy

Location

Related Publications (1)

• 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.

  PMID: 23753030 DERIVED

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

Rituximab; Cyclophosphamide; Cytarabine; Doxorubicin; Etoposide

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides

Study Officials

• Renato Bassan, MD

  USC Ematologia Ospedali Riuniti di Bergamo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 2, 2011
• First Posted: February 4, 2011
• Study Start: November 1, 2002
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

IT (12)