We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00445822
Recruitment Status : Unknown
Verified February 2012 by Technische Universität Dresden.
Recruitment status was:  Recruiting
First Posted : March 9, 2007
Last Update Posted : February 29, 2012
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief 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.

Condition or disease
Myeloid Leukemia, Chronic

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 150 participants
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)
Study Start Date : March 2007
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : December 2012


Groups and Cohorts


Outcome Measures

Biospecimen Retention:   Samples With DNA
Bone Marrow and blood smears

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Technische Universität Dresden
Medical Academy of Wroclaw, Poland
University of Leiden, Netherlands
Nordic Society for Pediatric Hematology and Oncology
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:
Suttorp M, Tauer JT, Millot F: Chronic myeloid leukemia in children: diagnostics and management Onkologie (CZ) 5(2):12-15, 2011

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
First Posted: March 9, 2007    Key Record Dates
Last Update Posted: February 29, 2012
Last Verified: February 2012

Keywords provided by Technische Universität Dresden:
CML
Children
Imatinib
bcr-abl
Response
Imatinib mesylate

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action