Bendamustine and Rituximab As Salvage Therapy In Patients... | NCT01224769

Studies
Bendamustine and Rituximab As Salvage Therapy In Patients With Chronic Lymphoproliferative Disorders

NCT01224769

Sponsor

Gruppo Italiano Studio Linfomi

Status

Completed

Last Update Posted

Oct 21, 2010Estimated

Enrollment

109Actual

Phase

Not provided

Conditions

Relapsed or Refractory Chronic Lymphoproliferative Disorders

Interventions

bendamustine +/- rituximab

Countries

Italy

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

Oct 2010

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

Sep 2005

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Oct 7, 2010

First Submission Date that Met QC Criteria

Oct 19, 2010

First Posted Date

Oct 20, 2010Estimated

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

Oct 20, 2010

Last Update Posted Date

Oct 21, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This retrospective study collects and evaluates the clinical experience reached in Italy on the use of bendamustine alone or combined with rituximab as treatment of patients with relapsed or refractory chronic lymphoproliferative disorders.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

109Actual

Label	Type	Description	Intervention Names
bendamustine +/- rituximab			Drug: bendamustine +/- rituximab

Name	Type	Description	Arm Group Labels	Other Names
bendamustine +/- rituximab	Drug		bendamustine +/- rituximab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall response rate		within 1 month after end of treatment

Secondary Outcomes

Measure	Description	Time Frame
grade III and IV (NCI Common Toxicity Criteria) adverse events		within 1 month after end of treatment
prognostic factors		within 1 month after end of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with relapsed or refractory chronic lymphoproliferative disorders
salvage treatment with bendamustine +/- rituximab
age ≥ 18 years

Exclusion Criteria:

previous treatment with bendamustine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients with relapsed or refractory chronic lymphoproliferative disorders treated with bendamustine +/- rituximab

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emilio Iannitto, MD	Gruppo Italiano Studio Linfomi	Study Chair
Fortunato Morabito, MD	Gruppo Italiano Studio Linfomi	Study Director
Stefano Luminari, MD	Gruppo Italiano Studio Linfomi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gruppo Italiano Studio Linfomi		Modena		41124	Italy

Condition Browse Module

MeSH Terms

ID	Term
D012008	Recurrence

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided