LMBA02 Protocol for Patients With a Burkitt Lymphoma

NCT ID: NCT00180882

Last Updated: 2006-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Burkitt Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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rituximab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Principal Investigators

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Vincent RIBRAG, MD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave Roussy

Villejuif, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Vincent RIBRAG, MD

Role: CONTACT

Phone: 33 1 42 11 43 47

Email: [email protected]

Facility Contacts

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Vincent RIBRAG, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 27080498 (View on PubMed)

Other Identifiers

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LMBA02

Identifier Type: -

Identifier Source: org_study_id