NCT00763763

Brief Summary

Patients not previously exposed to imatinib and with resistant or refractory Ph+ ALL, lymphoid blast crisis chronic myelogenous leukaemia (LBC CML) or with de novo Ph+ ALL and aged over 55y were eligible in the study. The DIV regimen consisted in one IV injection of vincristine 2 mg combined with 2 days of dexamethasone 40 mg PO repeated weekly for 4 weeks as induction and then monthly for 4 months as consolidation. Imatinib was administered at 800 mg per day during the induction period and at 600 mg/d continuously during consolidation. Patients in CR not eligible for HSCT were allocated to maintenance therapy consisting in weekly SC injection of Pegasys 45 µg and continuous administration of imatinib 400 mg per day for 2 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2004

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

December 1, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

October 5, 2011

Status Verified

October 1, 2011

Enrollment Period

2.8 years

First QC Date

July 25, 2008

Last Update Submit

October 4, 2011

Conditions

Leukemia, Lymphocytic, AcutePhiladelphia ChromosomeBlast CrisisLeukemia, Myeloid, Chronic

Keywords

Imatinib mesylateCombination therapyLeukemia, Lymphocytic, AcutePhiladelphia ChromosomeBlast CrisisLeukemia, Myeloid, Chronic

Outcome Measures

Primary Outcomes (1)

  • To determine the rate of hematological response induced by Gleevec™ combined with vincristine and dexamethasone

    After 35 days or 56 days of induction

Study Arms (1)

1

EXPERIMENTAL

imatinib in combination with chemotherapy by vincristin and dexamethasone

Drug: Imatinib mesylateDrug: InterferonDrug: VincristineDrug: Dexamethasone

Interventions

Imatinib mesylateDRUG

imatinib 600 mg/day for 2 years

Also known as: Interferon, Pegasys
1
InterferonDRUG

45 micrograms per week during 2 years

Also known as: Pegasys
1
VincristineDRUG

2 mg IV injection repeated weekly for 4 weeks as induction and then monthly for 4 months as consolidation

1
DexamethasoneDRUG

40 mg PO repeated weekly for 4 weeks as induction and then monthly for 4 months as consolidation

1

Eligibility Criteria

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

You may qualify if:

  • Male or female subjects over 18 years,
  • Poor prognosis BCR-ABL transcript-positive acute lymphoblastic leukemia (refractory or relapsing Ph+ ALL, BP lymphoid CML, BP lymphoid CML in relapse)

You may not qualify if:

  • Pregnant female,
  • Blastic involvement of the CNS,
  • Participation in an investigational agent trial within 4 weeks,
  • High dose therapy within 4 weeks,
  • Gleevec administration within 3 months,
  • Transaminases grade 3 or 4 elevation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Clinique des Maladies du Sang

Paris, Paris, 75010, France

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaPhiladelphia ChromosomeBlast CrisisLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib MesylateInterferonspeginterferon alfa-2aVincristineDexamethasone

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesTranslocation, GeneticChromosome AberrationsPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, MyeloidCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Philippe ROUSSELOT, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 25, 2008

First Posted

October 1, 2008

Study Start

December 1, 2004

Primary Completion

October 1, 2007

Study Completion

January 1, 2010

Last Updated

October 5, 2011

Record last verified: 2011-10

Locations

FR(1)