Multicenter Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
DECI2009
A Phase II Multicenter Open-label Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
1 other identifier
interventional
43
1 country
21
Brief Summary
The study aims to assess the activity of decitabine in the treatment of CMML.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2010
Longer than P75 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
December 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJune 25, 2018
June 1, 2018
1.7 years
December 1, 2010
June 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the activity of decitabine in the treatment of CMML
Activity will be evaluated as percentage of patients achieving complete or partial remission according to the International Working Group response criteria in myelodysplasia
24 months
Secondary Outcomes (1)
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
24 months
Study Arms (1)
Decitabine
EXPERIMENTALEligible 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients aged 18 and older
- CMML diagnosis according to WHO criteria
- If WBC\<=12000/mm3:IPSS High or INT-2
- If WBC\>12000/mm3: at least two of the following criteria:
- Blast cells\>5% in the bone marrow
- Citogenetic abnormality other then t(5;12) (q33;p13)
- Anemia (Hb\<10g/dl)
- Thrombocytopenia (Plt\<100000/mm3)
- Splenomegaly(\>5cm below costal margin)
- Extramedullary localization
- Performance Status ECOG 0,1 or 2
- Estimated life expectancy\>=6 months
- Adequate hepatic function:
- Total bilirubin \< 1.5 times upper limit of normal (except moderate unconjugate hyperbilirubinemia due to intra medullary hemolysis)
- AST and ALT \< 3 times limit of normal
- +5 more criteria
You may not qualify if:
- Myeloproliferative/myelodisplastic syndome othe than CMML
- Acute blastic transformation of CMML with bone marrow blast cells\>20%
- Patients eligible for allogenic bone marrow transplantation with identified donor
- CMML with t(5;12) o PDGFBR rearrangement
- Intensive chemotherapy given less than 3 months before
- Previous treatment with hypomethylating agent
- Age\< 18 years old
- Pregnancy or breastfeeding
- Performance Status ECOG\>2
- Estimate life expectancy\<6 months
- HIV infection
- Chronic active hepatitis secondary to HCV or HBV (HBSAq positive)
- Serious concomitantsystemic disorders, including active bacterial fungal or viral infection, that in the opinion of the investigator, would compromise the safety of the patient and/or his/her ability to complete the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Ematologia, Ospedale SS Antonio e Biagio e Cesare Arrigo
Alessandria, 15121, Italy
AOU Ospedali Riuniti di Ancona
Ancona, 60131, Italy
Ematologia AOU Policlinico di Bari
Bari, 70124, Italy
Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola
Bologna, 40100, Italy
Ematologia - Spedali Civili
Brescia, 25100, Italy
Ematologia- Ospedale Businco
Cagliari, 09121, Italy
Centro di ricerca e formazione ad alta tecnologia nelle Scienze, Università Cattolica
Campobasso, 86100, Italy
Cattedra di Ematologia Policlino Careggi
Florence, 50134, Italy
Dipartimento Emato-Oncologia AOU San Martino Genova
Genova, 16132, Italy
Fondazione IRCCS Caà Granda-Ospedale Maggiore policlinico
Milan, 20121, Italy
Divisione di Ematologia, Ospedale S.Gerardo di Monza
Monza, 20052, Italy
Divisione di Ematologia, Università Avogadro
Novara, 28100, Italy
Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga
Orbassano, 10043, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Ospedale S.Maria della Misericordia
Perugia, 06122, Italy
AOU San Salvatore
Pesaro, 61122, Italy
AO Bianchi Melacrino Morelli
Reggio Calabria, 89125, Italy
IRCCS Centri di riferimento oncologico
Rionero in Vulture, 85028, Italy
SC Ematologia AOU S.Andrea
Roma, 00183, Italy
Ematologia 2-Ospedale S.Giovanni Battista
Torino, 10126, Italy
U.O.Ematologia 2
Torino, 10126, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Santini Valeria, Professor
U.O di Ematologia, AO of Careggi, viale Morgagni n.85-50134-Firenze
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2010
First Posted
December 2, 2010
Study Start
April 1, 2010
Primary Completion
December 1, 2011
Study Completion
June 1, 2018
Last Updated
June 25, 2018
Record last verified: 2018-06