NCT00430066

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 8, 2014

Status Verified

October 1, 2014

Enrollment Period

2.8 years

First QC Date

January 31, 2007

Last Update Submit

October 7, 2014

Conditions

Polycythemia Vera

Outcome Measures

Primary Outcomes (1)

  • Reduction of Haematocrit to less than 45%.

    6-12 months

Secondary Outcomes (5)

  • Response duration

    6-12 months

  • Safety profile

    6-12 months

  • Reduction in platelet count and spleen size

    6-12 months

  • Reduction of incidence phlebotomies.

    6-12 months

  • Symptoms improvement in patients.

    6-12 months

Study Arms (1)

Imatinib Mesylate

EXPERIMENTAL

400 mg/day by mouth for 6 months (+ 6 months in case of responsiveness)

Drug: Imatinib Mesylate

Interventions

Imatinib MesylateDRUG

400 mg/die for 6 months

Imatinib Mesylate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycythemia Vera

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Bone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesMyeloproliferative Disorders

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Enrica Morra, MD

    Divisione di Ematologia - Ospedale Niguarda Ca' Granda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2007

First Posted

February 1, 2007

Study Start

February 1, 2007

Primary Completion

November 1, 2009

Study Completion

September 1, 2012

Last Updated

October 8, 2014

Record last verified: 2014-10