Study title
CML-Paed II = Registration of Children awith CML and Treatment with Imatinib
Scientific title
Protocol for standardized diagnostic procedures, registration, and treatment recommendations in children and adolescents with Philadelphia chromosome-positive chronic myeloid leukemia (CML) (EudraCT 2007-001339-69, ClinicalTrials.gov NCT00445822)
Indication and most important inclusion criteria
Newly diagnosed Ph+ or BCR-ABL-positive CML in children and adolescents under the age of 18 years. Potential study participants have not been pretreated with interferon alpha or any other cytostatic drug with the exception of hydroxyurea or anagrelide (Note: anagrelide is not approved in Germany for the treatment of CML). However, these patients may be registered as observational patients.
Short description of intervention
The objective of this study is to assess the antileukemic activity of imatinib in children and adolescents with newly diagnosed Ph+ or BCR-ABL-CML over a treatment period of two years. Primary endpoint is the rate of haematological, cytogenetical and molecular remissions.
Type of study
Paediatric trial
Current status
No longer recruiting
Study sponsor
Universität Dresden, Germany
Scientific lead / contact
Prof. Dr. Meinolf Suttorp
Principal investigator
Prof. Dr. Meinolf Suttorp
Universitätsklinikum Dresden
Bereich pädiatrische Hämatologie und Onkologie
Study centers / principal investigators
Centers of paediatric haematology oncology within the network of the Society for Paediatric Oncology and Haematology (GPOH) or of the national societies of Paediatric Oncology and Haematology
Additional information
Study description in ClinicalTrials.gov
Study protocol in English, Patient information in Germany, Fachinformation Glivec in German
Chronic Myeloid Leukemia
also called: Chronic Myelogeneous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
Philadelphia chromosome
A certain change in chromosomes (on chromosome 22) found in 95% of patients who have CML. The Philadelphia chromosome results from a mutation that involves the fusion of parts of chromosome 9 and chromosome 22 (the bcr-abl fusion gene)
Inclusion criteria
Inlusion criteria define which subjects may participate in a clinical study. Study subjects must fulfill all inclusion criteria (e.g. with regard to sex, age, previous diseases). This ensures a uniform composition of the study population and minimizes the risk of influences that distort the study results.
haematological
Relating to blood or the formation of blood
Also called: hematological
Chromosome
A chromosome is a structure of DNA that carries the genetic makeup in the nucleus of the cell. Chromosomes contain giant chain molecules of DNA, coiled and folded as aggregates with specific proteins. Chromosomes ensure that during cell division the hereditary information is evenly distributed to the daughter cells. Normal human body cells have 46 chromosomes. Cancer cells can have a different number and/or structure of chromosomes.
Indication
In medicine, a reason to use a certain diagnostic test, therapeutic procedure or medication. The opposite of indication is contraindication.
Protocol
The action plan for the research work, which explains key objectives and procedures. In case of a clinical trial, the protocol defines e.g. the purpose of the study, how many people will participate, eligibility criteria, the medical intervention, etc.
Imatinib
Imatinib, trade name Glivec/Gleevec, development name STI-571, a first-generation BCR-ABL tyrosine kinase inhibition. Authorized for marketing since 2002 for the treatment of CML and Ph-positive ALL.
Other names: Gleevec|Glivec
BCR-ABL
The abnormal gene that characterizes Chronic Myeloid Leukemia, which is a fusion of the BCR gene of chromosome 9 and the ABL gene of chromosome 22
Chronic
Long-lasting, slowly developping
Gene
A unit of information present as DNA; a gene usually contains the blueprint for a protein.
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
Ph+
Abbreviation for "Philadelphia-Chromosome-positive", meaning the presence of a certain change in chromosomes (on chromosome 22) found in 95% of patients who have CML. The Philadelphia chromosome results from a mutation that involves the fusion of parts of chromosome 9 and chromosome 22 (the bcr-abl fusion gene).
CHR
Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
