Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec®-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia
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|ClinicalTrials.gov Identifier: NCT00390897|
Recruitment Status : Completed
First Posted : October 23, 2006
Last Update Posted : November 27, 2008
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukaemia||Drug: Glivec Drug: Interferon||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Multicentre Phase IV Study to Compare Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec® in Combination With Interferon Alpha at Low Doses in the Treatment of Newly-Diagnosed Chronic-Phase Chronic Myeloid Leukaemia|
|Study Start Date :||July 2003|
|Primary Completion Date :||October 2006|
|Study Completion Date :||December 2007|
- The fundamental objective of this study is to compare the therapeutic efficacy of Glivec® given in monotherapy (providing for dose scaling according to the response obtained at different periods of time from the beginning) in combination with standard in
- The median survival of patients with CML is close to 7 years.
- One year and a half after diagnosis, the rate of progression to the acceleration phase and blastic crisis is very low (3.3%) in patients treated with Glivec® as first line.
- With the treatments available hitherto, the achievement of a major cytogenetic response and above all cytogenetic response translates into a prolongation of survival.
- Therefore, taking into account that the rate of complete cytogenetic responses to Glivec® in newly-diagnosed CML is 76% after 18 months of treatment (see table I), the fundamental objective of the study will be to compare the rate of complete cytogenetic
- The time until complete cytogenetic responses are obtained
- Rate of major cytogenetic responses
- Rate of molecular responses
- Time to the loss of cytogenetic, haematological or molecular response
- Time to the progression of the disease to the phases of acceleration and blastic crisis (analysed according to intention to treat)
- Survival (analysed according to intention to treat)
- Haematological and non haematological tolerance and safety
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390897
Show 51 Study Locations
|Study Chair:||Cervantes Francisco, Dr||Hospital Clinic of Barcelona|