Text Size

Registration of Children With CML and Treatment With Imatinib (CML-paed II)

This study is currently recruiting participants.
Verified February 2012 by Dresden University of Technology
Sponsor:
Collaborators:
Medical Academy of Wroclaw, Poland
University of Leiden, Netherlands
Nordic Pediatric Hematology Oncology Group, Scandinavia
Uniuversity of Genua, Italy
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00445822
First received: March 8, 2007
Last updated: February 28, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition
Myeloid Leukemia, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protocol for Standardized Diagnostic Procedures, Registration, and Treatment Recommendations in Children and Adolescents With Philadelphia Chromosome-positive Chronic Myeloid Leukemia (CML)

Resource links provided by NLM:

MedlinePlus related topics: Leukemia
U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Biospecimen Retention:   Samples With DNA

Bone Marrow and blood smears


Estimated Enrollment: 150
Study Start Date: March 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pts younger than 19 years with PH+ CML are recruited from primary care clinics

Criteria

Inclusion Criteria:

  • Newly diagnosed Ph+ or bcr-abl-positive CML
  • Male and female patients aged 0 to 18 years
  • Written informed consent

Exclusion Criteria:

  • CML without bcr-abl rearrangement detectable by PCR
  • Pretreatment with Interferon alpha or any other cytostatic drug with the exception of hydroxyurea or anagrelide (Note: anagrelide is not approved in Germany for treatment of CML). However, these patients may be registered as observational patients.
  • Any other severe underlying disease beside CML.
  • Age > 18 years- Pregnant or lactating women
  • Subjects unlikely to comply with the requirements of the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445822

Contacts
Contact: Meinolf Suttorp, Prof. Dr. +49 351 458 ext 3522 meinolf.suttorp@uniklinikum-dresden.de
Contact: Xenia Graehlert, Dr. +49 351 458 ext 5160 grahlert@uniklinikum-dresden.de

Locations
Germany
University Children's Hopsital, Technical University of Dresden, Fetscherstr. 74 Recruiting
Dresden, Saxonia, Germany, D-01307
Contact: Meinolf Suttorp, Prof. Dr.     +49 351 458 ext 3522     meinolf.suttorp@uniklinikum-dresden.de    
Sponsors and Collaborators
Dresden University of Technology
Medical Academy of Wroclaw, Poland
University of Leiden, Netherlands
Nordic Pediatric Hematology Oncology Group, Scandinavia
Uniuversity of Genua, Italy
Investigators
Principal Investigator: Meinolf Suttorp, Prof. Dr. University Children's Hospital, Dpt. Ped. Hemato-Oncology, Technical University of Dresden, Germany
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. Meinolf Suttorp, Universitätskinderklinik Dresden
ClinicalTrials.gov Identifier: NCT00445822     History of Changes
Other Study ID Numbers: TUD-CML-paed 016, EudraCT: 2007-001339-69
Study First Received: March 8, 2007
Last Updated: February 28, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Dresden University of Technology:
CML
Children
Imatinib
 bcr-abl
Response
Imatinib mesylate

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
 Chromosome Aberrations
Pathologic Processes
Disease Attributes
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013