NCT00858806

Brief Summary

Standard therapy with Imatinib (IM) significantly prolongs the survival of Ph+CML patients who obtain a complete cytogenetic response (CCgR). Elderly patients (i.e., at least 65 years) have similar cytogenetic responses and survival, but they usually show a low compliance. The aim of the study is to evaluate the percentage of elderly patients who maintain a CCgR with intermittent imatinib therapy with respect to standard daily administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

April 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

2.7 years

First QC Date

March 9, 2009

Last Update Submit

December 2, 2014

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients who remain in CCgR with INTERIM given for one year.

    1 year

Secondary Outcomes (1)

  • Variation of BCR-ABL transcript level

    1 year

Study Arms (1)

Intermittent Imatinib

EXPERIMENTAL

Imatinib will be given with the following schedule: * 1 week on / 1 week off for the 1st month(weeks 1-4) * 2 weeks on / 2 weeks off for the 2nd and the 3rd month (weeks 5-12) * 1 month on / 1 month off from the 4th month thereafter (weeks 13 on)

Drug: Imatinib

Interventions

ImatinibDRUG

Intermittent Imatinib administration. * 1 week on / 1 week off for the 1st month(weeks 1-4) * 2 weeks on / 2 weeks off for the 2nd and the 3rd month (weeks 5-12) * 1 month on / 1 month off from the 4th month thereafter (weeks 13 on)

Also known as: glivec
Intermittent Imatinib

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients with confirmed diagnosis of Ph+ CML in CP
  • Age ≥ 65 years old
  • Stable CCgR after at least 2 years of treatment with standard (daily administration) IM therapy documented by 2 consecutive cytogenetic analysis over the last 12 month
  • Karnofsky performance status \>50%
  • Written informed consent prior to any study procedures being performed.

You may not qualify if:

  • Patients with Ph+ CML in accelerated/blastic phase (AP/BP), or in late CP, previously treated (i.e. IFN alpha+/- low dose Ara-C, Hydroxyurea, allogeneic stem cell transplantation, etc etc.)
  • Age \< 65 years old
  • No stable CCgR after at least 2 years of treatment with standard (daily administration) IM therapy documented by 2 consecutive cytogenetic analysis over the last 12 month
  • Karnofsky performance status \<50%
  • No written informed consent prior to any study procedures being performed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chair of Haematology, Bone Marrow Transplant Unit

Brescia, Brescia, 25123, Italy

Location

Related Publications (1)

  • Russo D, Martinelli G, Malagola M, Skert C, Soverini S, Iacobucci I, De Vivo A, Testoni N, Castagnetti F, Gugliotta G, Turri D, Bergamaschi M, Pregno P, Pungolino E, Stagno F, Breccia M, Martino B, Intermesoli T, Fava C, Abruzzese E, Tiribelli M, Bigazzi C, Cesana BM, Rosti G, Baccarani M. Effects and outcome of a policy of intermittent imatinib treatment in elderly patients with chronic myeloid leukemia. Blood. 2013 Jun 27;121(26):5138-44. doi: 10.1182/blood-2013-01-480194. Epub 2013 May 15.

    PMID: 23678005DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Prof Domenico Russo, MD

    Chair of Haematology, Brescia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Hematology

Study Record Dates

First Submitted

March 9, 2009

First Posted

March 10, 2009

Study Start

April 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

IT(1)