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Treatment Modification Based on Early Assessment of CML Patients

NCT01762969 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2013-01-08

No results posted yet for this study

Summary

The investigators will check the feasibility of using early molecular response for making treatment decisions. Patients diagnosed with chronic myeloid leukemia will commence imatinib treatment. After 3 months of treatment their response will be assessed. If molecular response would be less the 10% (BCR-ABL1/ABL ISI \>10%)imatinib therapy will be stopped and patients will start a different TKI (as nilotinib, dasatinib). The investigators will follow on lab and clinical outcomes.

Conditions

  • CML

Interventions

OTHER

Treatment modification based on molecular response at 3 months

Patients will be treated with imatinib upon diagnosis of CML. Molecular response will be assessed at 3 months of therapy. Based on molecular response imatinib will be continued or changed to another TKI

Sponsors & Collaborators

  • Rambam Health Care Campus

    collaborator OTHER

  • Wolfson Medical Center

    collaborator OTHER_GOV

  • Bnai Zion Medical Center

    collaborator OTHER_GOV

  • HaEmek Medical Center, Israel

    collaborator OTHER

  • Hadassah Medical Organization

    collaborator OTHER

  • Rabin Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2019-01-31
Completion
2020-01-31

Countries

  • Israel

Study Locations

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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 NCT01762969 on ClinicalTrials.gov