LMBA02 Protocol for Patients With a Burkitt Lymphoma

NCT00180882 | Unknown Phase 3

• 1 other identifier: LMBA02
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

To explore in a multicenter international prospective randomized study (phase III) whether rituximab combined with the standard French LMB chemotherapy scheme results in a higher rate of EFS than the LMB chemotherapy scheme alone in patients older than 18 years with Burkitt lymphoma or ALL 3.

Conditions

Burkitt Lymphoma

Outcome Measures

Primary Outcomes (1)

• Event free survival from date of first randomization

Secondary Outcomes (1)

• Complete and partial response rate, overall survival, toxicity

Interventions

rituximab DRUG

Eligibility Criteria

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

You may qualify if:

• Age : 18 years or older
• Histologically or cytologically proven Burkitt lymphoma according to the WHO classification
• WHO performance \< 3
• Informed consent

You may not qualify if:

• Known HIV positive infection
• Positive serology for HCV and HBV (except after vaccination)
• Patients previously treated for lymphoma
• cardiac disease that contradict anthracycline chemotherapy
• Psychological or psychiatric condition who contradict steroids therapy
• Patients with serious renal failure unrelated to the lymphoma (serum creatinin level higher than 150 mmole/L)
• Cirrhosis or severe hepatic failure unrelated to the lymphoma
• Previous malignant disease except basal cell skin carcinoma or in situ uterine cervix carcinoma
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Primary organ transplant or other immunosuppressive conditions Pregnancy

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94800, France

RECRUITING

Related Publications (1)

• Ribrag V, Koscielny S, Bosq J, Leguay T, Casasnovas O, Fornecker LM, Recher C, Ghesquieres H, Morschhauser F, Girault S, Le Gouill S, Ojeda-Uribe M, Mariette C, Cornillon J, Cartron G, Verge V, Chassagne-Clement C, Dombret H, Coiffier B, Lamy T, Tilly H, Salles G. Rituximab and dose-dense chemotherapy for adults with Burkitt's lymphoma: a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Jun 11;387(10036):2402-11. doi: 10.1016/S0140-6736(15)01317-3. Epub 2016 Apr 11.

  PMID: 27080498 DERIVED

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

Rituximab

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

Study Officials

• Vincent RIBRAG, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent RIBRAG, MD

CONTACT

33 1 42 11 43 47; ribrag@igr.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: October 1, 2004
• Last Updated: September 11, 2006

Record last verified: 2006-09

Locations

FR (1)