Chronic Myelomonocytic LeukemiaPhase 2DECI2009NCT01251627
Multicenter Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
A Phase 2 study testing Decitabine in people with Chronic Myelomonocytic Leukemia, run by Fondazione Italiana Sindromi Mielodisplastiche-ETS at 21 sites in Italy.
Trial summary
The study aims to assess the activity of decitabine in the treatment of CMML. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Chronic Myelomonocytic Leukemia
- What is being tested?
- Decitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 21 sitesItaly
- Study dates
- Apr 2010to Jun 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Italy21 sites
Ematologia, Ospedale SS Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
AOU Ospedali Riuniti di Ancona
Ancona, 60131
Ematologia AOU Policlinico di Bari
Bari, 70124
Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola
Bologna, 40100
Ematologia - Spedali Civili
Brescia, 25100
Ematologia- Ospedale Businco
Cagliari, 09121
Centro di ricerca e formazione ad alta tecnologia nelle Scienze, Università Cattolica
Campobasso, 86100
Cattedra di Ematologia Policlino Careggi
Florence, 50134
Dipartimento Emato-Oncologia AOU San Martino Genova
Genova, 16132
Fondazione IRCCS Caà Granda-Ospedale Maggiore policlinico
Milan, 20121
Divisione di Ematologia, Ospedale S.Gerardo di Monza
Monza, 20052
Divisione di Ematologia, Università Avogadro
Novara, 28100
Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga
Orbassano, 10043
Azienda Ospedaliera di Padova
Padova, 35128
Ospedale S.Maria della Misericordia
Perugia, 06122
AOU San Salvatore
Pesaro, 61122
AO Bianchi Melacrino Morelli
Reggio Calabria, 89125
IRCCS Centri di riferimento oncologico
Rionero in Vulture, 85028
SC Ematologia AOU S.Andrea
Roma, 00183
Ematologia 2-Ospedale S.Giovanni Battista
Torino, 10126
U.O.Ematologia 2
Torino, 10126
About this study
Official title: A Phase II Multicenter Open-label Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
The study aims to assess the activity of decitabine in the treatment of CMML.
- Conditions
- Chronic Myelomonocytic Leukemia
- Being tested
- Decitabine
- Keywords
- Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Decitabine
- Medical subject headings
- Leukemia, Myelomonocytic, Chronic, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Decitabine | Experimental | 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. Receives: Drug: Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelomonocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Sindromi Mielodisplastiche-ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
- Responsible party
- Sponsor
- Investigators
- Santini Valeria, Professor, Principal investigator, U.O di Ematologia, AO of Careggi, viale Morgagni n.85-50134-Firenze
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251627
- Sponsor's protocol ID
- DECI2009-AISSM06
- Acronym
- DECI2009
- Status last verified
- Jun 2018
- First submitted
- 1 Dec 2010
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter Open-label Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
- ClinicalTrials.gov ID
- NCT01251627
- Acronym / sponsor ID
- DECI2009 / DECI2009-AISSM06
- Conditions
- Chronic Myelomonocytic Leukemia
- Keywords
- Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Decitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Fondazione Italiana Sindromi Mielodisplastiche-ETSUniversity, hospital or other
- Collaborators
- Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to assess the activity of decitabine in the treatment of CMML.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decitabine | Experimental | Drug: DecitabineEligible 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients aged 18 and older
- CMML diagnosis according to WHO criteria
- If WBC<=12000/mm3:IPSS High or INT-2
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DecitabineDecitabine 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. | Drug | Decitabine |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santini Valeria, Professor principal investigator
U.O di Ematologia, AO of Careggi, viale Morgagni n.85-50134-Firenze
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decitabine in people with Chronic Myelomonocytic Leukemia, run by Fondazione Italiana Sindromi Mielodisplastiche-ETS at 21 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the activity of decitabine in the treatment of CMML (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.