Treatment of Aggressive Localized Lymphoma
Overview[ - collapse ][ - ]
Purpose | Prospective and multicentric Phase III study, evaluation of the interest of the radiotherapy after 4 or 6 cycles of CHOP 14 R regimen of chemotherapy , patients with agressive and localized B lymphoma , age 18 to 75 years. |
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Condition | B Cell Lymphoma |
Intervention | Drug: rituximab Drug: doxorubicin Drug: vincristine Drug: prednisone Procedure: radiotherapy |
Phase | Phase 3 |
Sponsor | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
Responsible Party | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
ClinicalTrials.gov Identifier | NCT00841945 |
First Received | February 11, 2009 |
Last Updated | October 31, 2013 |
Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | February 11, 2009 |
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Last Updated Date | October 31, 2013 |
Start Date | April 2005 |
Estimated Primary Completion Date | June 2014 |
Current Primary Outcome Measures | Event Free Survival (EFS) and Progression Free Survival (PFS) [Time Frame: EFS PFS one year after treatment] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Treatment of Aggressive Localized Lymphoma |
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Official Title | Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy , Patients With Agressive Localized Lymphoma |
Brief Summary | Prospective and multicentric Phase III study, evaluation of the interest of the radiotherapy after 4 or 6 cycles of CHOP 14 R regimen of chemotherapy , patients with agressive and localized B lymphoma , age 18 to 75 years. |
Detailed Description | CHOP 14 R regimen of chemotherapy is a good standard in the treatment of agressive and localized B lymphoma. Interest of the radiotheraphy |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | B Cell Lymphoma |
Intervention | Drug: rituximab RITUXIMAB 375 MG/M² IV DAY 1 or each course Other Names: MABTHERADrug: doxorubicin doxorubicin 50 mg / m² iv day 1 of each course Other Names: AdriblastineDrug: vincristine VINCRISTINE 1?4 MG/M² IV ON DAY 1 Other Names: OncovinDrug: prednisone Prednisone 40 mg/m² DAy 1 to day 5 Other Names: solupredProcedure: radiotherapy radiotherapy : total dose = 40 GY (5 fractions by week) Other Names: no other name |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 400 |
Estimated Completion Date | June 2014 |
Estimated Primary Completion Date | October 2013 |
Eligibility Criteria | Inclusion Criteria: - Age > 18 and < 75 years - Diffuse B large cell lymphoma , CD 20+ - Ann Arbor stage I or II withe a bulk <7 cm - stage i ou II confirmed by the PET-scan - No previously treated - HIV negative - Signed Informed consent Exclusion Criteria: - Age< 18 and > 75 years - other type of lymphoma - CD20 negative - Ann Arbor stage >II or bulk > 7 cm - HIV positive - Contraindication to Rituximab use according to Sm PC - Containdication to antracyclin - cancer or history of cancer , excepted in situ cancer of the cervix or skin epithelioma - Refusal of sign the informed consent |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Thierry LAMY, MD Ph D +33 2 99 28 42 91 thierry.lamy@univ-rennes1.fr |
Location Countries | France |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00841945 |
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Other Study ID Numbers | GOELAMS 02 03 |
Has Data Monitoring Committee | Yes |
Information Provided By | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
Study Sponsor | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
Collaborators | Not Provided |
Investigators | Principal Investigator: Thierry LAMY, MD PhD Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
Verification Date | October 2013 |
Locations[ + expand ][ + ]
Regional university hospital | Rennes, France, 35033 Contact: Thierry LAMY, MD PhD | + 33 2 99 28 42 91 | thierry.lamy@univ-rennes1.frRecruiting |
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