Diffuse Large B Cell Lymphoma of the Adult: Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14-Rituximab

Lymphoma, Large-Cell, Diffuse Clinical Trial

Official title:

Frontline Therapy of Diffuse Large B Cell Lymphoma of the Adult ( 18 to 60 Years Old): Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14 -Rituximab. Multicentric Randomized Prospective Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561379
• Other study ID #: BRD 04/4-O
• Status: Completed
• Phase: N/A
• First received: November 20, 2007
• Last updated: June 12, 2013
• Start date: April 2005
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The aim of the protocol is to compare the outcome of patients with DLBCL stage II bulky, III or IV with 1 to 3 adverse prognostic factors according to the International prognostic index. Patients with eligibility criteria and who gave informed consent will be randomised between CHOP-14- Rituximab x 8 courses and High dose chemotherapy with rituximab including autologous stem cell support. The aim of the study is to compare the Event free survival between the two arms and to gain insight into the prognostic significance of several biological markers gathered at the time of diagnosis/randomisation ( i.e. Fcgamma R III A genotyping, DNA profile and BCL é expression).

Description:

Diffuse Large B Cell Lymphoma not previously treated

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age = 18 et = 60 and male and female

• Diffuse large B cell lymphoma according to WHO classification phénotype B CD 20 +

• Stage I et II tumor bulk > 7 cm and stage III et IV Ann Arbor.

• Non previously treated

• HIV négative

• Signed informed consent

Exclusion Criteria:

• Age < 18 and/or > 60 ans

• NHL not DLBCL

• Lymphoblastic Lymphoma

• Burkitt's Lymphoma

• Low grade Lymphoma transformed

• Primary CNS Lymphomal

• Post- transplantation Lymphoma

• CD20 negative

• Ann Arbor stage I or II without tumor bulk > 7 cm

• Previous treatment

• HIV positive

• Contre-indication to Rituximab use according to SmPC

• Contre-indication to high dose chemotherapy due to organ failure not related to the lymphoma

• Cancer or history of cancer with the exception of in situ cancer of the cervix or non-invasive skin epithelioma

• Patient not able to understand the proposed treatments

• Refusal to sign the informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Large-Cell, Diffuse

Intervention

Drug:
• CHOP+RITUXIMAB
CHOP-14- Rituximab x 8 courses
• CEEP-RITUXIMAB
High dose chemotherapy with rituximab including autologous stem cell support.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 years Event-free survival ( Kaplan Meier method)
Secondary	3 years overall survival
Secondary	Prognostic impact of: Level of expression of protéine bcl2 protein in tumor cells; FCGR3A genotype; génomic profile (DNA microarray)on response, survival, and Event-Free-Survival
Secondary	Cost