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STI571 ProspectIve RandomIzed Trial: SPIRIT

NCT00219739 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 789

Last updated 2020-04-13

No results posted yet for this study

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.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

Imatinib mesylate 400 mg

DRUG

Imatinib mesylate 600 mg

DRUG

Imatinib 400 mg + Peg-Interferon

DRUG

Imatinib mesylate 400 mg + Cytarabine

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Novartis

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • Poitiers University Hospital

    lead OTHER

Principal Investigators

  • François GUILHOT, MD · Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00219739 on ClinicalTrials.gov