NCT00219739

Brief Summary

To test whether increasing the dose of imatinib or combining it with IFNalpha or ara-C increases the rate of molecular response (as measured by the decrease in BCR-ABL transcripts after 12 months of treatment) in patients with previously untreated CML in chronic phase. To compare overall survival in a selected arm according to molecular response at 1 year from randomization with the reference arm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
789

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_3

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

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 13, 2020

Status Verified

June 1, 2016

Enrollment Period

11.3 years

First QC Date

September 13, 2005

Last Update Submit

April 10, 2020

Conditions

Chronic Myeloid Leukemia

Keywords

CMLImatinibInterferonCytarabine

Outcome Measures

Primary Outcomes (1)

  • Overall survival improvement

Secondary Outcomes (5)

  • Molecular response improvement at 1 year

    1 year

  • Hematological, cytogenetic responses improvement

    1 year

  • Duration of responses improvement

  • Survival without progression improvement

  • Acceptable toxicity

Study Arms (4)

Imatinib mesylate 400 mg

EXPERIMENTAL
Drug: Imatinib mesylate 400 mgDrug: Imatinib mesylate 600 mgDrug: Imatinib 400 mg + Peg-InterferonDrug: Imatinib mesylate 400 mg + Cytarabine

Imatinib mesylate 600 mg

EXPERIMENTAL
Drug: Imatinib mesylate 400 mgDrug: Imatinib mesylate 600 mgDrug: Imatinib 400 mg + Peg-InterferonDrug: Imatinib mesylate 400 mg + Cytarabine

Imatinib mesylate 400 mg +Peg interferon

EXPERIMENTAL
Drug: Imatinib mesylate 400 mgDrug: Imatinib mesylate 600 mgDrug: Imatinib 400 mg + Peg-InterferonDrug: Imatinib mesylate 400 mg + Cytarabine

Imatinib mesylate 400 mg +Cytarabine

EXPERIMENTAL
Drug: Imatinib mesylate 400 mgDrug: Imatinib mesylate 600 mgDrug: Imatinib 400 mg + Peg-InterferonDrug: Imatinib mesylate 400 mg + Cytarabine

Interventions

Imatinib mesylate 400 mgDRUG
Imatinib mesylate 400 mgImatinib mesylate 400 mg +CytarabineImatinib mesylate 400 mg +Peg interferonImatinib mesylate 600 mg
Imatinib mesylate 600 mgDRUG
Imatinib mesylate 400 mgImatinib mesylate 400 mg +CytarabineImatinib mesylate 400 mg +Peg interferonImatinib mesylate 600 mg
Imatinib 400 mg + Peg-InterferonDRUG
Imatinib mesylate 400 mgImatinib mesylate 400 mg +CytarabineImatinib mesylate 400 mg +Peg interferonImatinib mesylate 600 mg
Imatinib mesylate 400 mg + CytarabineDRUG
Imatinib mesylate 400 mgImatinib mesylate 400 mg +CytarabineImatinib mesylate 400 mg +Peg interferonImatinib mesylate 600 mg

Eligibility Criteria

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

You may qualify if:

  • Patients over 18 years of age
  • Patients with Bcr-Abl positive CML in chronic phase.
  • Patients within 14 weeks of diagnosis and previously untreated for CML except for hydroxyurea and/or anagrelide.
  • No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly
  • ECOG performance score of 0-2
  • acceptable hepatic, renal, and cardiac function
  • Informed consent signed up

You may not qualify if:

  • Depressive syndrome not controlled
  • Uncontrolled medical illnesses.
  • Women with childbearing potential and male patients who are unwilling or unable to use an adequate method to avoid pregancy for the entire period of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Poitiers, 86021, France

Location

Related Publications (4)

  • Bruzzoni-Giovanelli H, Gonzalez JR, Sigaux F, Villoutreix BO, Cayuela JM, Guilhot J, Preudhomme C, Guilhot F, Poyet JL, Rousselot P. Genetic polymorphisms associated with increased risk of developing chronic myelogenous leukemia. Oncotarget. 2015 Nov 3;6(34):36269-77. doi: 10.18632/oncotarget.5915.

    PMID: 26474455DERIVED

  • Delord M, Rousselot P, Cayuela JM, Sigaux F, Guilhot J, Preudhomme C, Guilhot F, Loiseau P, Raffoux E, Geromin D, Genin E, Calvo F, Bruzzoni-Giovanelli H. High imatinib dose overcomes insufficient response associated with ABCG2 haplotype in chronic myelogenous leukemia patients. Oncotarget. 2013 Oct;4(10):1582-91. doi: 10.18632/oncotarget.1050.

    PMID: 24123600DERIVED

  • Johnson-Ansah H, Guilhot J, Rousselot P, Rea D, Legros L, Rigal-Huguet F, Nicolini FE, Mahon FX, Preudhomme C, Guilhot F. Tolerability and efficacy of pegylated interferon-alpha-2a in combination with imatinib for patients with chronic-phase chronic myeloid leukemia. Cancer. 2013 Dec 15;119(24):4284-9. doi: 10.1002/cncr.28328. Epub 2013 Sep 16.

    PMID: 24105694DERIVED

  • Preudhomme C, Guilhot J, Nicolini FE, Guerci-Bresler A, Rigal-Huguet F, Maloisel F, Coiteux V, Gardembas M, Berthou C, Vekhoff A, Rea D, Jourdan E, Allard C, Delmer A, Rousselot P, Legros L, Berger M, Corm S, Etienne G, Roche-Lestienne C, Eclache V, Mahon FX, Guilhot F; SPIRIT Investigators; France Intergroupe des Leucemies Myeloides Chroniques (Fi-LMC). Imatinib plus peginterferon alfa-2a in chronic myeloid leukemia. N Engl J Med. 2010 Dec 23;363(26):2511-21. doi: 10.1056/NEJMoa1004095.

    PMID: 21175313DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib MesylateCytarabine

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 CompoundsPyrimidinesCytidinePyrimidine NucleosidesArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • François GUILHOT, MD

    Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

September 1, 2003

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 13, 2020

Record last verified: 2016-06

Locations

FR(1)