NCT00787384

Brief Summary

The study was performed to assess: 1) clinical activity of Imatinib in patients with HES, CEL and CIH; 2) correlation between Imatinib activity and specific disease subtype; 3) long-term outcome of HES, CEL and CIH patients treated with Imatinib; 4) safety and tolerability of Imatinib administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2004

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2008

Completed
Last Updated

December 29, 2010

Status Verified

December 1, 2010

Enrollment Period

3.2 years

First QC Date

November 6, 2008

Last Update Submit

December 28, 2010

Conditions

Hypereosinophilic SyndromeChronic Eosinophilic LeukemiaChronic Idiopathic Hypereosinophilia

Keywords

Hypereosinophilic syndrome (HES)chronic eosinophilic leukaemia (CEL)chronic idiopathic hypereosinophilia (CIH)ImatinibResponseTiming to response

Outcome Measures

Primary Outcomes (1)

  • Response rate

Secondary Outcomes (4)

  • Safety: Adverse events and serious adverse events

  • Time to response

  • Diagnostic profile of Imatinib-responsive cases

  • Duration of responses following drug withdrawal after 12 weeks

Study Arms (1)

Imatinib

EXPERIMENTAL

Patients received oral imatinib 100 mg/d; in case of unsatisfactory response (less than complete) Imatinib could be increased by 100 mg/die on a weekly basis and up to a maximum of 400 mg/die. Imatinib was discontinued after 12 total weeks of therapy.

Drug: Imatinib

Interventions

ImatinibDRUG

Patients received oral imatinib 100 mg/d; in case of unsatisfactory response (less than complete) Imatinib could be increased by 100 mg/die on a weekly basis and up to a maximum of 400 mg/die. Imatinib wsa discontinued after 12 total weeks of therapy.

Also known as: Gleevec
Imatinib

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with a diagnosis of HES, CEL and CIH, who are either previously untreated or have been treated with corticosteroids, cytotoxic drugs, and IFN.
  • age \> 15 years.
  • signature of a written informed consent(by parents/tutors for patients aged \< 18 years).

You may not qualify if:

  • patients with a diagnosis of secondary hypereosinophilia
  • age \< 15 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

USC Ematologia Ospedali Riuniti di Bergamo

Bergamo, Bergamo, 24128, Italy

Location

Divisione di Ematologia Spedali Civili di Brescia

Brescia, Brescia, Italy

Location

USC Ematologia Azienda Ospedaliera Università Careggi

Florence, Firenze, 50134, Italy

Location

UO Ematologia, Azienda Ospedaliera ULSS6

Vicenza, Vicenza, 36100, Italy

Location

Related Publications (1)

  • Intermesoli T, Delaini F, Acerboni S, Salmoiraghi S, Spinelli O, Guerini V, Vannucchi AM, Mappa S, Rossi G, Rossi V, Di Bona E, Paratore S, Carobbio A, Rambaldi A, Barbui T, Bassan R. A short low-dose imatinib trial allows rapid identification of responsive patients in hypereosinophilic syndromes. Br J Haematol. 2009 Dec;147(5):681-5. doi: 10.1111/j.1365-2141.2009.07893.x. Epub 2009 Sep 4.

    PMID: 19735261RESULT

MeSH Terms

Conditions

Hypereosinophilic SyndromePdgfra-Associated Chronic Eosinophilic Leukemia

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

EosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Renato Bassan, MD

    USC Ematologia Ospedali Riuniti di Bergamo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2008

First Posted

November 7, 2008

Study Start

October 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

December 29, 2010

Record last verified: 2010-12

Locations

IT(4)