Multicenter Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia (DECI2009)
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|ClinicalTrials.gov Identifier: NCT01251627|
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myelomonocytic Leukemia||Drug: Decitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Multicenter Open-label Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||June 2018|
Eligible patients will recieve Dacogen 20mg/m2 in 1 hour iv infusion for 5 days every 28 days (1 cycle)plus Best Supportive Care.A total of 6 courses is planned.
Decitabine will be administered at a dose of 20 mg/m2 infused over a 1 hour period once daily for 5 consecutive days. The totale amount per course is 100 mg/m2. Cycles will be administered every 4 weeks (1 cycle of 28 days).It is recommented that patients be treated for a minimum of 4 cycles.
- To assess the activity of decitabine in the treatment of CMML [ Time Frame: 24 months ]Activity will be evaluated as percentage of patients achieving complete or partial remission according to the International Working Group response criteria in myelodysplasia
- to assess the activity of decitabine in the treatment of CMML in terms of overall survival, time to leukemic transormation, response duration in terms of time to relapse after CR, PR, time to disease progression, ecc [ Time Frame: 24 months ]
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): NCT01251627
|Principal Investigator:||Santini Valeria, Professor||U.O di Ematologia, AO of Careggi, viale Morgagni n.85-50134-Firenze|