Diffuse Large B Cell Lymphoma of the Adult: Randomization... | NCT00561379

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

NCT00561379

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Jun 13, 2013Estimated

Enrollment

350Estimated

Phase

Not Applicable

Conditions

Lymphoma, Large-Cell, Diffuse

Interventions

CHOP+RITUXIMAB
CEEP-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

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Nov 20, 2007

First Submission Date that Met QC Criteria

Nov 20, 2007

First Posted Date

Nov 21, 2007Estimated

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

Jun 12, 2013

Last Update Posted Date

Jun 13, 2013Estimated

Description Module

Brief 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).

Detailed Description

Diffuse Large B Cell Lymphoma not previously treated

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: CHOP+RITUXIMAB
2	Active Comparator		Drug: CEEP-RITUXIMAB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CHOP+RITUXIMAB	Drug	CHOP-14- Rituximab x 8 courses	1
CEEP-RITUXIMAB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3 years Event-free survival ( Kaplan Meier method)

Secondary Outcomes

Measure	Description	Time Frame
3 years overall survival
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Noel Milpied, MD	University Hospital, Bordeaux	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nantes University Hospital		Nantes			France

Condition Browse Module

MeSH Terms

ID	Term
D016403	Lymphoma, Large B-Cell, Diffuse

Ancestor Terms

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided