Myeloid Leukemia, ChronicCML-paed IINCT00445822
Registration of Children With CML and Treatment With Imatinib
An observational study of Myeloid Leukemia, Chronic, run by Technische Universität Dresden at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Myeloid Leukemia, Chronic
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2007to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pts younger than 19 years with PH+ CML are recruited from primary care clinics
Who may be able to join
- Newly diagnosed Ph+ or bcr-abl-positive CML
- Male and female patients aged 0 to 18 years
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Children's Hopsital, Technical University of Dresden, Fetscherstr. 74
Dresden, Saxony, D-01307
Meinolf Suttorp, Prof. Dr., +49 351 458 ext. 3522, meinolf.suttorp@uniklinikum-dresden.de
About this study
Official title: Protocol for Standardized Diagnostic Procedures, Registration, and Treatment Recommendations in Children and Adolescents With Philadelphia Chromosome-positive Chronic Myeloid Leukemia (CML)
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.
Read the detailed description
Indication:
Newly diagnosed pediatric patients with bcr-abl-positive CML.
Design:
Multicenter, non-randomized, open, prospective clinical trial.
Objectives:
Primary:
- assessment of antileukemic activity of imatinib in children and adolescents with Philadelphia chromosome-positive chronic myeloid leukemia
Secondary:
- assessment of the time-to event-efficacy variables
- correlation of the quality of haematological, cytogenetical and molecular remission in children and adolescents with CML on ongoing imatinib therapy with survival
- safety of imatinib
Endpoints:
Primary:
- rate of haematological, cytogenetical and molecular remissions
Secondary:
- time to progression
- duration of chronic phase
- time to loss of response
- overall survival
- assessment of treatment-related toxicities in children and adolescents.
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
Number of patients to be enrolled: 150
Recruitment period: 5 years
Treatment period: 2 years
Planned start of study: 2007
Planned end of study: 2013
- Conditions
- Myeloid Leukemia, Chronic
- Keywords
- CML, Children, Imatinib, bcr-abl, Response, Imatinib mesylate
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJul 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Myeloid Leukemia, ChronicStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Academy of Wroclaw, Poland, University of Leiden, Netherlands, Nordic Society for Pediatric Hematology and Oncology, University of Genua, Italy
- Investigators
- Meinolf Suttorp, Prof. Dr., Principal investigator, University Children's Hospital, Dpt. Ped. Hemato-Oncology, Technical University of Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445822
- Sponsor's protocol ID
- TUD-CML-paed 016
- Other IDs
- EudraCT: 2007-001339-69
- Acronym
- CML-paed II
- Status last verified
- Feb 2012
- First submitted
- 8 Mar 2007
- Last updated
- 29 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16341042Adler 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.
PubMed 19067742Suttorp 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.
PubMed 18978743Schmid 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.
PubMed 19546438Bacher 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.
PubMed 19319532Suttorp 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.
PubMed 21239821Suttorp 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.
PubMed 21195300Suttorp 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.
PubMed 19890786Suttorp M, Tauer JT, Millot F: Chronic myeloid leukemia in children: diagnostics and management Onkologie (CZ) 5(2):12-15, 2011
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.
PubMed 20145269Stiehler 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.
PubMed 38497150Knofler 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.
PubMed 31617211Ulmer 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.
PubMed 23716272Jaeger 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.
PubMed 23197234
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Standardized Diagnostic Procedures, Registration, and Treatment Recommendations in Children and Adolescents With Philadelphia Chromosome-positive Chronic Myeloid Leukemia (CML)
- ClinicalTrials.gov ID
- NCT00445822
- Acronym / sponsor ID
- CML-paed II / TUD-CML-paed 016
- Conditions
- Myeloid Leukemia, Chronic
- Keywords
- CML, Children, Imatinib, bcr-abl, Response, Imatinib mesylate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Medical Academy of Wroclaw, Poland, University of Leiden, Netherlands, Nordic Society for Pediatric Hematology and Oncology, University of Genua, Italy
- Study start
- Mar 2007
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 9 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Indication:
Newly diagnosed pediatric patients with bcr-abl-positive CML.
Design:
Multicenter, non-randomized, open, prospective clinical trial.
Objectives:
Primary:
- assessment of antileukemic activity of imatinib in children and adolescents with Philadelphia chromosome-positive chronic myeloid leukemia
Secondary:
- assessment of the time-to event-efficacy variables
- correlation of the quality of haematological, cytogenetical and molecular remission in children and adolescents with CML on ongoing imatinib therapy with survival
- safety of imatinib
Endpoints:
Primary:
- rate of haematological, cytogenetical and molecular remissions
Secondary:
- time to progression
- duration of chronic phase
- time to loss of response
- overall survival
- assessment of treatment-related toxicities in children and adolescents.
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
Number of patients to be enrolled: 150
Recruitment period: 5 years
Treatment period: 2 years
Planned start of study: 2007
Planned end of study: 2013
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pts younger than 19 years with PH+ CML are recruited from primary care clinics
Key inclusion criteria (3 listed)
- Newly diagnosed Ph+ or bcr-abl-positive CML
- Male and female patients aged 0 to 18 years
- Written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2012.
- Background: PubMed 16341042Millot 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.
- Background: PubMed 19067742Adler 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.
- Background: PubMed 18978743Suttorp 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.
- Background: PubMed 19546438Schmid 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.
- Background: PubMed 19319532Bacher 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.
- Background: PubMed 21239821Suttorp 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.
- Background: PubMed 21195300Suttorp 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.
- Background: PubMed 19890786Suttorp 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.
- BackgroundSuttorp M, Tauer JT, Millot F: Chronic myeloid leukemia in children: diagnostics and management Onkologie (CZ) 5(2):12-15, 2011
- Results publication: PubMed 20145269Suttorp 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.
- Derived from this study: PubMed 38497150Stiehler 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.
- Derived from this study: PubMed 31617211Knofler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meinolf Suttorp, Prof. Dr. principal investigator
University Children's Hospital, Dpt. Ped. Hemato-Oncology, Technical University of Dresden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloid Leukemia, Chronic, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meinolf Suttorp, Prof. Dr. (+49 351 458 ext. 3522, meinolf.suttorp@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00445822, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2012.