Effects of Imatinib Mesylate in Polycythemia Vera | NCT00430066

Studies
Effects of Imatinib Mesylate in Polycythemia Vera

NCT00430066

Sponsor

Niguarda Hospital

Status

Completed

Last Update Posted

Oct 8, 2014Estimated

Enrollment

9Actual

Phase

Phase 2

Conditions

Polycythemia Vera

Interventions

Imatinib Mesylate

Countries

Not provided

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 2014

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

Feb 2007

Primary Completion Date

Nov 2009Actual

Completion Date

Sep 2012Actual

First Submitted Date

Jan 31, 2007

First Submission Date that Met QC Criteria

Jan 31, 2007

First Posted Date

Feb 1, 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

Oct 7, 2014

Last Update Posted Date

Oct 8, 2014Estimated

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

The purpose of this study is to determine the activity of Glivec 400 mg po daily, as single agent, in inducing a haematological response in Polycythemia Vera.

The patients will be asked to have additional bone marrow and blood samples collected: these samples will be used to evaluate how the disease is responding to the drug.

Detailed Description

Hematocrit <45% in men or <42% in women at 1°evaluation within 6 months In case of complete or partial responsiveness, experimental treatment will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study

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

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Imatinib Mesylate	Experimental	400 mg/day by mouth for 6 months (+ 6 months in case of responsiveness)	Drug: Imatinib Mesylate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imatinib Mesylate	Drug	400 mg/die for 6 months	Imatinib Mesylate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of Haematocrit to less than 45%.		6-12 months

Secondary Outcomes

Measure	Description	Time Frame
Response duration		6-12 months
Safety profile		6-12 months
Reduction in platelet count and spleen size

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Polycythemia Vera requiring treatment with either phlebotomy or Hydroxyurea
Age >18 years
Signed written informed consent form

Exclusion Criteria:

Pregnancy or breast-feeding
Creatinine >3 max NV
Bilirubin >3 max NV
AST/ALT >3 max NV
Concomitant and severe psychiatric disorder
Concomitant neoplastic disease

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Enrica Morra, MD	Divisione di Ematologia - Ospedale Niguarda Ca' Granda	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011087	Polycythemia Vera

Ancestor Terms

ID	Term
D019046	Bone Marrow Neoplasms
D019337	Hematologic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068877	Imatinib Mesylate

Ancestor Terms

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146

Browse Leaves

Not provided

Browse Branches

Not provided