Registration of Children With CML and Treatment With Imatinib

NCT00445822 | Unknown DMC

• 2 other identifiers: TUD-CML-paed 016EudraCT: 2007-001339-69
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloid Leukemia, Chronic

Keywords

CML; Children; Imatinib; bcr-abl; Response; Imatinib mesylate

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Medical Academy of Wroclaw, Poland: collaborator
• University of Leiden, Netherlands: collaborator
• Nordic Society for Pediatric Hematology and Oncology: collaborator
• University of Genua, Italy: collaborator

Study Sites (1)

University Children's Hopsital, Technical University of Dresden, Fetscherstr. 74

Dresden, Saxony, D-01307, Germany

RECRUITING

Related Publications (14)

• Millot F, Guilhot J, Nelken B, Leblanc T, De Bont ES, Bekassy AN, Gadner H, Sufliarska S, Stary J, Gschaidmeier H, Guilhot F, Suttorp M. Imatinib mesylate is effective in children with chronic myelogenous leukemia in late chronic and advanced phase and in relapse after stem cell transplantation. Leukemia. 2006 Feb;20(2):187-92. doi: 10.1038/sj.leu.2404051.

  PMID: 16341042 BACKGROUND

• Adler R, Viehmann S, Kuhlisch E, Martiniak Y, Rottgers S, Harbott J, Suttorp M. Correlation of BCR/ABL transcript variants with patients' characteristics in childhood chronic myeloid leukaemia. Eur J Haematol. 2009 Feb;82(2):112-8. doi: 10.1111/j.1600-0609.2008.01170.x. Epub 2008 Nov 10.

  PMID: 19067742 BACKGROUND

• Suttorp M. Innovative approaches of targeted therapy for CML of childhood in combination with paediatric haematopoietic SCT. Bone Marrow Transplant. 2008 Oct;42 Suppl 2:S40-6. doi: 10.1038/bmt.2008.282.

  PMID: 18978743 BACKGROUND

• Schmid H, Jaeger BA, Lohse J, Suttorp M. Longitudinal growth retardation in a prepuberal girl with chronic myeloid leukemia on long-term treatment with imatinib. Haematologica. 2009 Aug;94(8):1177-9. doi: 10.3324/haematol.2009.008359. Epub 2009 Jun 22. No abstract available.

  PMID: 19546438 BACKGROUND

• Bacher U, Klyuchnikov E, Zabelina T, Ottinger H, Beelen DW, Schrezenmeier H, Ehninger G, Muller C, Berger J, Suttorp M, Kolb HJ, Kroger N, Zander AR. The changing scene of allogeneic stem cell transplantation for chronic myeloid leukemia--a report from the German Registry covering the period from 1998 to 2004. Ann Hematol. 2009 Dec;88(12):1237-47. doi: 10.1007/s00277-009-0737-3. Epub 2009 Mar 25.

  PMID: 19319532 BACKGROUND

• Suttorp M, Millot F. Treatment of pediatric chronic myeloid leukemia in the year 2010: use of tyrosine kinase inhibitors and stem-cell transplantation. Hematology Am Soc Hematol Educ Program. 2010;2010:368-76. doi: 10.1182/asheducation-2010.1.368.

  PMID: 21239821 BACKGROUND

• Suttorp M, Yaniv I, Schultz KR. Controversies in the treatment of CML in children and adolescents: TKIs versus BMT? Biol Blood Marrow Transplant. 2011 Jan;17(1 Suppl):S115-22. doi: 10.1016/j.bbmt.2010.09.003.

  PMID: 21195300 BACKGROUND

• Suttorp M, Claviez A, Bader P, Peters C, Gadner H, Ebell W, Dilloo D, Kremens B, Kabisch H, Fuhrer M, Zintl F, Gobel U, Klingebiel T. Allogeneic stem cell transplantation for pediatric and adolescent patients with CML: results from the prospective trial CML-paed I. Klin Padiatr. 2009 Nov-Dec;221(6):351-7. doi: 10.1055/s-0029-1239529. Epub 2009 Nov 4.

  PMID: 19890786 BACKGROUND

• Suttorp M, Tauer JT, Millot F: Chronic myeloid leukemia in children: diagnostics and management Onkologie (CZ) 5(2):12-15, 2011

  BACKGROUND

• Suttorp M, Thiede C, Tauer JT, Range U, Schlegelberger B, von Neuhoff N. Impact of the type of the BCR-ABL fusion transcript on the molecular response in pediatric patients with chronic myeloid leukemia. Haematologica. 2010 May;95(5):852-3. doi: 10.3324/haematol.2009.019224. Epub 2010 Feb 9. No abstract available.

  PMID: 20145269 RESULT

• Stiehler S, Sembill S, Schleicher O, Marx M, Rauh M, Krumbholz M, Karow A, Suttorp M, Woelfle J, Maj C, Metzler M. Imatinib treatment and longitudinal growth in pediatric patients with chronic myeloid leukemia: influence of demographic, pharmacological, and genetic factors in the German CML-PAED cohort. Haematologica. 2024 Aug 1;109(8):2555-2563. doi: 10.3324/haematol.2023.284668.

  PMID: 38497150 DERIVED

• Knofler R, Lange BS, Paul F, Tiebel O, Suttorp M. Bleeding signs due to acquired von Willebrand syndrome at diagnosis of chronic myeloid leukaemia in children. Br J Haematol. 2020 Mar;188(5):701-706. doi: 10.1111/bjh.16241. Epub 2019 Oct 15.

  PMID: 31617211 DERIVED

• Ulmer A, Tabea Tauer J, Glauche I, Jung R, Suttorp M. TK inhibitor treatment disrupts growth hormone axis: clinical observations in children with CML and experimental data from a juvenile animal model. Klin Padiatr. 2013 May;225(3):120-6. doi: 10.1055/s-0033-1343483. Epub 2013 May 28.

  PMID: 23716272 DERIVED

• Jaeger BA, Tauer JT, Ulmer A, Kuhlisch E, Roth HJ, Suttorp M. Changes in bone metabolic parameters in children with chronic myeloid leukemia on imatinib treatment. Med Sci Monit. 2012 Dec;18(12):CR721-8. doi: 10.12659/msm.883599.

  PMID: 23197234 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Bone Marrow and blood smears

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Meinolf Suttorp, Prof. Dr.

  University Children's Hospital, Dpt. Ped. Hemato-Oncology, Technical University of Dresden, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meinolf Suttorp, Prof. Dr.

CONTACT

+49 351 458; meinolf.suttorp@uniklinikum-dresden.de

Xenia Graehlert, Dr.

CONTACT

+49 351 458; grahlert@uniklinikum-dresden.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2007
• First Posted: March 9, 2007
• Study Start: March 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 29, 2012

Record last verified: 2012-02

Locations

DE (1)