Registration of Children With CML and Treatment With Imatinib

NCT00445822 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2012-02-29

No results posted yet for this study

Summary

Newly diagnosed pediatric patients (age \< 19 years) with bcr-abl-positive CML will be treated with imatinib. Serial monitoring of treatment response is performed in one month intervals during the first three months of treatment and in three months intervals thereafter. Patients with non-response, poor response (either molecular, cytogenetic, or hematologic non-/poor response) or progress of the disease while under imatinib treatment will stop imatinib and undergo stem cell transplantation. All responders to imatinib treatment with an HLA matched donor will undergo stem cell transplantation not later than 2 years after diagnosis.

Conditions

  • Myeloid Leukemia, Chronic

Sponsors & Collaborators

  • Medical Academy of Wroclaw, Poland

    collaborator UNKNOWN
  • University of Leiden, Netherlands

    collaborator UNKNOWN
  • Nordic Society for Pediatric Hematology and Oncology

    collaborator OTHER
  • Uniuversity of Genua, Italy

    collaborator OTHER
  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Meinolf Suttorp, Prof. Dr. · University Children's Hospital, Dpt. Ped. Hemato-Oncology, Technical University of Dresden, Germany

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2012-07-31
Completion
2012-12-31

Countries

  • Germany

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 NCT00445822 on ClinicalTrials.gov