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.
ConditionB Cell Lymphoma
InterventionDrug: rituximab
Drug: doxorubicin
Drug: vincristine
Drug: prednisone
Procedure: radiotherapy
PhasePhase 3
SponsorGroupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Responsible PartyGroupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov IdentifierNCT00841945
First ReceivedFebruary 11, 2009
Last UpdatedOctober 31, 2013
Last verifiedOctober 2013

Tracking Information[ + expand ][ + ]

First Received DateFebruary 11, 2009
Last Updated DateOctober 31, 2013
Start DateApril 2005
Estimated Primary Completion DateJune 2014
Current Primary Outcome MeasuresEvent 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
  • Pet-scan [Time Frame: pronostic impact of Pet-scan] [Designated as safety issue: Yes]
  • radiotherapy [Time Frame: Toxicity of the radiotherapy] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleTreatment of Aggressive Localized Lymphoma
Official TitlePhase 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 TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionB Cell Lymphoma
InterventionDrug: 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)
  • Active Comparator: 1
    Chemotherapy + Radiotherapy
    - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
    Radiotherapy 40 gray on initial nodes
  • Experimental: 2
    Chemotherapy
    - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment400
Estimated Completion DateJune 2014
Estimated Primary Completion DateOctober 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Thierry LAMY, MD Ph D
+33 2 99 28 42 91
thierry.lamy@univ-rennes1.fr
Location CountriesFrance

Administrative Information[ + expand ][ + ]

NCT Number NCT00841945
Other Study ID NumbersGOELAMS 02 03
Has Data Monitoring CommitteeYes
Information Provided ByGroupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Study SponsorGroupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
CollaboratorsNot Provided
Investigators Principal Investigator: Thierry LAMY, MD PhD Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Verification DateOctober 2013

Locations[ + expand ][ + ]

Regional university hospital
Rennes, France, 35033
Contact: Thierry LAMY, MD PhD | + 33 2 99 28 42 91 | thierry.lamy@univ-rennes1.fr
Recruiting