Treatment of Aggressive Localized Lymphoma

B Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00841945
• Other study ID #: GOELAMS 02 03
• Status: Terminated
• Phase: Phase 3
• First received: February 11, 2009
• Last updated: February 20, 2017
• Start date: April 2005
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

CHOP 14 R regimen of chemotherapy is a good standard in the treatment of agressive and localized B lymphoma.

Interest of the radiotheraphy

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 334
• Est. completion date: February 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

Drug:
• rituximab
RITUXIMAB 375 MG/M² IV DAY 1 or each course
• doxorubicin
doxorubicin 50 mg / m² iv day 1 of each course
• vincristine
VINCRISTINE 1?4 MG/M² IV ON DAY 1
• prednisone
Prednisone 40 mg/m² DAy 1 to day 5

Procedure:
• radiotherapy
radiotherapy : total dose = 40 GY (5 fractions by week)

Locations

Country	Name	City	State
France	Regional university hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
French Innovative Leukemia Organisation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Free Survival (EFS) and Progression Free Survival (PFS)		EFS PFS one year after treatment
Secondary	Pet-scan		pronostic impact of Pet-scan
Secondary	radiotherapy		Toxicity of the radiotherapy

External Links

•   FILO website