Back to resultsMulticenter Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia (DECI2009)
Primary Purpose
Chronic Myelomonocytic Leukemia
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Decitabine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myelomonocytic Leukemia focused on measuring Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Decitabine
Eligibility Criteria
Inclusion Criteria:
- 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
- Patients untretaed or previously treated with Hydroxyurea or Imatinib or Etoposide given orally or non intensive chemotherapy or intensive chemotherapy given more thann 3 months befor inclusion
- 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
Adequate renal function:
- Serum creatinine < 1.5 times limit of normal
- Creatinine clearance > 30ml/min
- Informed consent
- Negative pregnancy test or adequate contraception methods
Exclusion Criteria:
- 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
Sites / Locations
- Ematologia, Ospedale SS Antonio e Biagio e Cesare Arrigo
- AOU Ospedali Riuniti di Ancona
- Ematologia AOU Policlinico di Bari
- Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola
- Ematologia - Spedali Civili
- Ematologia- Ospedale Businco
- Centro di ricerca e formazione ad alta tecnologia nelle Scienze, Università Cattolica
- Cattedra di Ematologia Policlino Careggi
- Dipartimento Emato-Oncologia AOU San Martino Genova
- Fondazione IRCCS Caà Granda-Ospedale Maggiore policlinico
- Divisione di Ematologia, Ospedale S.Gerardo di Monza
- Divisione di Ematologia, Università Avogadro
- Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga
- Azienda Ospedaliera di Padova
- Ospedale S.Maria della Misericordia
- AOU San Salvatore
- AO Bianchi Melacrino Morelli
- IRCCS Centri di riferimento oncologico
- SC Ematologia AOU S.Andrea
- Ematologia 2-Ospedale S.Giovanni Battista
- U.O.Ematologia 2
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Decitabine
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01251627
First Posted
December 1, 2010
Last Updated
June 21, 2018
Sponsor
Fondazione Italiana Sindromi Mielodisplastiche-ETS
Collaborators
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
1. Study Identification
Unique Protocol Identification Number
NCT01251627
Brief Title
Multicenter Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
Acronym
DECI2009
Official Title
A Phase II Multicenter Open-label Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Italiana Sindromi Mielodisplastiche-ETS
Collaborators
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to assess the activity of decitabine in the treatment of CMML.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelomonocytic Leukemia
Keywords
Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Decitabine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decitabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Decitabine
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the activity of decitabine in the treatment of CMML
Description
Activity will be evaluated as percentage of patients achieving complete or partial remission according to the International Working Group response criteria in myelodysplasia
Time Frame
24 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Patients untretaed or previously treated with Hydroxyurea or Imatinib or Etoposide given orally or non intensive chemotherapy or intensive chemotherapy given more thann 3 months befor inclusion
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
Adequate renal function:
Serum creatinine < 1.5 times limit of normal
Creatinine clearance > 30ml/min
Informed consent
Negative pregnancy test or adequate contraception methods
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santini Valeria, Professor
Organizational Affiliation
U.O di Ematologia, AO of Careggi, viale Morgagni n.85-50134-Firenze
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ematologia, Ospedale SS Antonio e Biagio e Cesare Arrigo
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Facility Name
AOU Ospedali Riuniti di Ancona
City
Ancona
ZIP/Postal Code
60131
Country
Italy
Facility Name
Ematologia AOU Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola
City
Bologna
ZIP/Postal Code
40100
Country
Italy
Facility Name
Ematologia - Spedali Civili
City
Brescia
ZIP/Postal Code
25100
Country
Italy
Facility Name
Ematologia- Ospedale Businco
City
Cagliari
ZIP/Postal Code
09121
Country
Italy
Facility Name
Centro di ricerca e formazione ad alta tecnologia nelle Scienze, Università Cattolica
City
Campobasso
ZIP/Postal Code
86100
Country
Italy
Facility Name
Cattedra di Ematologia Policlino Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Dipartimento Emato-Oncologia AOU San Martino Genova
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione IRCCS Caà Granda-Ospedale Maggiore policlinico
City
Milano
ZIP/Postal Code
20121
Country
Italy
Facility Name
Divisione di Ematologia, Ospedale S.Gerardo di Monza
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Divisione di Ematologia, Università Avogadro
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedale S.Maria della Misericordia
City
Perugia
ZIP/Postal Code
06122
Country
Italy
Facility Name
AOU San Salvatore
City
Pesaro
ZIP/Postal Code
61122
Country
Italy
Facility Name
AO Bianchi Melacrino Morelli
City
Reggio Calabria
ZIP/Postal Code
89125
Country
Italy
Facility Name
IRCCS Centri di riferimento oncologico
City
Rionero in Vulture
ZIP/Postal Code
85028
Country
Italy
Facility Name
SC Ematologia AOU S.Andrea
City
Roma
ZIP/Postal Code
00183
Country
Italy
Facility Name
Ematologia 2-Ospedale S.Giovanni Battista
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
U.O.Ematologia 2
City
Torino
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Multicenter Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
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