Glivec in Pediatric Chronic Myeloid Leukemia (CML)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Poitiers University Hospital.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Poitiers University Hospital
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT00845221
First received: February 16, 2009
Last updated: February 17, 2009
Last verified: February 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
It is a phase 4 study, not randomised and multicentric. Within 2 months after the diagnosis, the patients daily receive imatinib by oral way during at least 1 year (260mg/m² once a day), i.e. until the cytogenetic analysis.
Beyond 1 year of treatment, if a haematological relapse or a loss of the cytogenetic response is observed, the nature of the treatment suggested to the patient is left with the appreciation of the investigator.
Later on, discontinuation of imatinib is discussed if a molecular remission (negative RT-PCR) is obtained and maintained for at least 2 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloid Leukemia |
Drug: Imatinib mesylate 100 mg (Glivec) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
Resource links provided by NLM:
Further study details as provided by Poitiers University Hospital:
| Enrollment: | 44 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | December 2011 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Imatinib |
Drug: Imatinib mesylate 100 mg (Glivec)
260 mg/m2/day tablets
|
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Old < 18 years, male or female.
- Chronic myeloid leukaemia confirmed on the cytogenetic level by the presence of the translocation t(9; 22) (q34; q11) or by the presence of transcript BCR-ABL in the event of absence of description of the translocation t(9; 22) (q34; q11).
- Chronic phase of a chronic myeloid leukaemia
- Absence of extra-medullary disease (except for a hepatomegaly and/or of a splenomegaly).
- Absence of any former treatment of chronic myeloid leukaemia except for hydroxyurea.
- Stop of hydroxyurea at least week before the beginning of the imatinib mesylate.
- Diagnosis of chronic myeloid leukaemia in chronic phase recent (less than 2 months).
- Score of Lansky ≥ 60.
- Effective contraception among patients in age to procreate.
- Written voluntary informed consent of the two parents or the legal guardian.
Exclusion Criteria:
- Patients with grade 3 / 4 cardiac disease.
- Pathology cardiac, pulmonary, hepatic, renal or neurological of grade > 2 (WHO).
- Participation in a clinical trial in the 28 days preceding the beginning by the treatment.
- Impossible Follow-up during at least 2 years, patient not compliant.
- Expectant mother or nursing.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845221
Locations
| France | |
| CHU Amiens | |
| Amiens, France, 80000 | |
| Hôpital La Timone - CHU de Marseille | |
| Marseille, France, 13385 | |
| Hôpital de Brabois - CHU de Nancy | |
| Vendoeuvre les Nancy, France, 54511 | |
Sponsors and Collaborators
Poitiers University Hospital
More Information
No publications provided
| Responsible Party: | Docteur Frédéric MILLOT/principal investigator, CHU DE POITIERS |
| ClinicalTrials.gov Identifier: | NCT00845221 History of Changes |
| Other Study ID Numbers: | GLIVEC PHASE IV |
| Study First Received: | February 16, 2009 |
| Last Updated: | February 17, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
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 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013