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An international collaborative study to discontinue Imatinib/Glivec® in pediatric CML patients with sustained complete molecular response (STOPIMAPED).


- candidate number12395
- NTR NumberNTR3452
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-mei-2012
- Secondary IDs2011-006239-44 / NL37603.042.11; METC / CCMO
- Public TitleAn international collaborative study to discontinue Imatinib/Glivec® in pediatric CML patients with sustained complete molecular response (STOPIMAPED).
- Scientific TitleAn international collaborative study to discontinue Imatinib/Glivec® in pediatric CML patients with sustained complete molecular response.
- ACRONYMSTOPIMAPED
- hypothesis1. To estimate the percentage of quantitative RT-PCR negative pediatric CML patients in which Imatinib discontinuation result in sustained complete molecular remission;
2. To determine whether restarting of Imatinib or another tyrosine kinase inhibitor in case of molecular relapse results in a molecular remission again.
- Healt Condition(s) or Problem(s) studiedChronic Myeloid Leukemia (CML), Children, Complete molecular response, Imatinib
- Inclusion criteria1. Pediatric CML patients treated with Imatinib having achieved and maintained complete molecular remission for at least 2 years;
2. Informed consent needs to be signed.
- Exclusion criteriaNon-CML patients, or CML patients with complete cytogenetic reponse but with a moderate molecular response.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2012
- planned closingdate1-jun-2016
- Target number of participants60
- Interventions1. Stop Imatinib/Glivec;
2. Start Imatinib/Glivec or other inhabitor in case of relapse.

Chronic myeloid leukemia is a rare disease in children; SEER databases record an incidence of 2% of all leukemias in children < 15 years (accounting for 1 case/million/year) increasing up to 9% in children aged 15-19 years (2.2 cases/million/year).
Presently treatment consists of BCR/ABL kinase inhibitors as first choice drugs, in both adults and children. Stem cell transplantations are now considered as a second treatment option due to its severe morbidity in terms of quality of life (infertility, second malignancies e.d.). Recently, several adverse long-term effects have been described in adult patients as well as in scarce reports in children treated with BCR/ABL kinase inhibitors, such as imatinib. In adults aberrant bone composition has been reported. Especially in children decreased growth development, and incomplete pubertal development are reported as a result of long-term treatment with tyrosine kinase inhibitors such as Imatinib. These side effects made us aware that long term treatment of growing and developing children with tyrosine kinase inhibitors results in long term side effects of treatment.
In the meantime, promising results are described in small series of adult CML patients in which imatinib is stopped; 40% remained in a complete molecular response. Most patients (>90%) with molecular relapse experienced this relapse early (<7 months) after stopping Imatinib. All relapsed patients achieved a second molecular remission after restarting Imatinib.
The possibility of imatinib discontinuation needs to be explored as a possible final solution for the disease and long-term side effects in children. Many adolescents already discontinue Imatinib themselves. The international CML treating physicians of the IBFM are confronted with drug discontinuation of several patients themselves, or with reasons such as impaired growth development and/or complications or toxicity.
The IBFM CML study group (an international group of experts in this field) supports this international study. This international collaborative study will determine the efficacy of discontinuation of Imatinib on sustaines complete molecular response in Philadelphia positive CML pediatric patients treated with Imatinib.
- Primary outcome1. Molecular relapse free survival at 6 and 24 months;
2. Duration of complete molecular remission after stopping Imatinib.
- Secondary outcome1. Prognostic studies;
2. Overall survival and survival without progression;
3. Efficacy of restarting Imatinib in a period of 6 months after molecular relapse.
- TimepointsIntensive follow up will last 24 months after discontinuation of Imatinib. Blood samples for BCR/ABL PCR have to be evaluated at least every 4 weeks or more frequently within the local institution and/or centrally depending on the regulations for each country. Restmaterial will be stored. When the BCR/ABL shows ongoing complete molecular remission the patient will continue without Imatinib. However, when a loss of Complete Molecular Response is encountered a new blood sample has to be drawn within 2 weeks and the finding of BCR/ABL positive PCR has to be confirmed in the institution as well as in the referral laboratory for the country following the guidelines for each collaborating country.

In case of molecular relapse, patients should be restarted and resume the identical dose per m2 of Imatinib or another tyrosine kinase inhibitor immediately following a complete diagnostic work-up according to local policy. In the bone marrow aspirate cytogenetic and molecular analysis for BCR/ABL needs to be performed. Response on restarting treatment will be measured by molecular analysis of peripheral blood/bone marrow aspirates. The results need to be reported for the study at 1, 3, and 6 months.
- Trial web sitewww.skion.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES L. Scheffers
- CONTACT for SCIENTIFIC QUERIESProf. dr. E.S.J.M. Bont, de
- Sponsor/Initiator Stichting Kinder Oncologie (SKION)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Kinderoncologie Nederland (SKION)
- PublicationsN/A
- Brief summaryChronic myeloid leukemia is a rare disease in children; SEER databases record an incidence of 2% of all leukemias in children < 15 years (accounting for 1 case/million/year) increasing up to 9% in children aged 15-19 years (2.2 cases/million/year).
Presently treatment consists of BCR/ABL kinase inhibitors as first choice drugs, in both adults and children. Stem cell transplantations are now considered as a second treatment option due to its severe morbidity in terms of quality of life (infertility, second malignancies e.d.).
Recently, several adverse long-term effects have been described in adult patients as well as in scarce reports in children treated with BCR/ABL kinase inhibitors, such as imatinib. In adults aberrant bone composition has been reported. Especially in children decreased growth development, and incomplete pubertal development are reported as a result of long-term treatment with tyrosine kinase inhibitors such as Imatinib. These side effects made us aware that long term treatment of growing and developing children with tyrosine kinase inhibitors results in long term side effects of treatment.
In the meantime, promising results are described in small series of adult CML patients in which imatinib is stopped; 40% remained in a complete molecular response. Most patients (>90%) with molecular relapse experienced this relapse early (<7 months) after stopping Imatinib. All relapsed patients achieved a second molecular remission after restarting Imatinib.
The possibility of imatinib discontinuation needs to be explored as a possible final solution for the disease and long-term side effects in children. Many adolescents already discontinue Imatinib themselves. The international CML treating physicians of the IBFM are confronted with drug discontinuation of several patients themselves, or with reasons such as impaired growth development and/or complications or toxicity.
The IBFM CML study group (an international group of experts in this field) supports this international study. This international collaborative study will determine the efficacy of discontinuation of Imatinib on sustaines complete molecular response in Philadelphia positive CML pediatric patients treated with Imatinib.
- Main changes (audit trail)
- RECORD21-mei-2012 - 11-jun-2012


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