LMBA02 Protocol for Patients With a Burkitt Lymphoma | NCT00180882

Studies
LMBA02 Protocol for Patients With a Burkitt Lymphoma

NCT00180882

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Unknown status

Last Update Posted

Sep 11, 2006Estimated

Enrollment

260

Phase

Phase 3

Conditions

Burkitt Lymphoma

Interventions

rituximab

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2006

Last Update Posted Date

Sep 11, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

260

Name	Type	Description	Arm Group Labels	Other Names
rituximab	Drug

Measure	Description	Time Frame
Event free survival from date of first randomization

Measure	Description	Time Frame
Complete and partial response rate, overall survival, toxicity

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vincent RIBRAG, MD	Contact	33 1 42 11 43 47		ribrag@igr.fr

Overall Officials

Name	Affiliation	Role
Vincent RIBRAG, MD	Gustave Roussy, Cancer Campus, Grand Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave Roussy	Recruiting	Villejuif		94800	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27080498	Derived	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.

ID	Term
D020031	Epstein-Barr Virus Infections
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins