LMBA02 Protocol for Patients With a Burkitt Lymphoma

Burkitt Lymphoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00180882
• Other study ID #: LMBA02
• Status: Recruiting
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: September 7, 2006
• Start date: October 2004

Study information

• Verified date: September 2006
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Vincent RIBRAG, MD
• Phone: 33 1 42 11 43 47
• Email: ribrag[@]igr.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age : 18 years or older

• Histologically or cytologically proven Burkitt lymphoma according to the WHO classification

• WHO performance < 3

• Informed consent

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burkitt Lymphoma

Intervention

Drug:
• rituximab

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival from date of first randomization
Secondary	Complete and partial response rate, overall survival, toxicity