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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00180882
Other study ID # LMBA02
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
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