High-dose Chemotherapy With Rituximab for Adults With Agg... | NCT00965289

Studies
High-dose Chemotherapy With Rituximab for Adults With Aggressive Large B-cell Lymphoma

NCT00965289

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Aug 26, 2009Estimated

Enrollment

42Actual

Phase

Phase 2

Conditions

B-Cell Lymphoma

Interventions

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

Aug 2009

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 2002

Primary Completion Date

May 2003Actual

Completion Date

Jun 2009Actual

First Submitted Date

Aug 24, 2009

First Submission Date that Met QC Criteria

Aug 24, 2009

First Posted Date

Aug 25, 2009Estimated

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

Aug 25, 2009

Last Update Posted Date

Aug 26, 2009Estimated

Name	Class
French Innovative Leukemia Organisation	OTHER
Hoffmann-La Roche	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI, up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.

Detailed Description

Superiority of HDT with autologous stem cell transplantation (ASCT) in the upfront treatment of poor-risk DLBCL remains an option for intermediate-high (IH) or high IPI young adults. We updated results of the prospective trial Goelams 074 to evaluate long-term efficacy and toxicity in 42 patients who underwent HDT with ASCT.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HDT combined with rituximab before ASCT	Experimental	The study treatment consisted on 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.	Drug: Rituximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rituximab	Drug	Rituximab infusion on day 1 dose: 375mg/m²	HDT combined with rituximab before ASCT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CR rate after 3 high dose chemotherapy courses		safety/efficacy of chemotherapy treatment

Secondary Outcomes

Measure	Description	Time Frame
CR and PR rate at the end of the study treatment		safety/efficacy of treatment30 days after the end of post ASCT aplasia
PFS,EFS and OS		safety/efficacy of study treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 to 60 y.o
Aggressive Large B-Cell Lymphoma (CD20+)
Ann Arbor stage III, IV
IH or high adjusted IPI
signed inform consent

Exclusion Criteria:

Age < 18 ou > 60 y.o
other type of lymphoma
serology VIH +
other neoplasms apart from basal cell carcinoma or situ carcinoma

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, PD MS	CHU NANTES/GOELAMS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Nantes		44000	France

Condition Browse Module

MeSH Terms

ID	Term
D016393	Lymphoma, B-Cell

Ancestor Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069283	Rituximab

Ancestor Terms

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided