Clinical trial NCT01251627: Multicenter Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Myelomonocytic Leukemia
Keywords: Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Decitabine
Lead sponsor: Fondazione Italiana Sindromi Mielodisplastiche-ETS
Sponsor class: OTHER
Collaborators: name: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
First posted: 2010-12-02
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aims to assess the activity of decitabine in the treatment of CMML.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 and older
2. CMML diagnosis according to WHO criteria
3. 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
4. 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
5. Performance Status ECOG 0,1 or 2
6. Estimated life expectancy\>=6 months
7. 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
8. Adequate renal function:

   * Serum creatinine \< 1.5 times limit of normal
   * Creatinine clearance \> 30ml/min
9. Informed consent
10. Negative pregnancy test or adequate contraception methods

Exclusion Criteria:

1. Myeloproliferative/myelodisplastic syndome othe than CMML
2. Acute blastic transformation of CMML with bone marrow blast cells\>20%
3. Patients eligible for allogenic bone marrow transplantation with identified donor
4. CMML with t(5;12) o PDGFBR rearrangement
5. Intensive chemotherapy given less than 3 months before
6. Previous treatment with hypomethylating agent
7. Age\< 18 years old
8. Pregnancy or breastfeeding
9. Performance Status ECOG\>2
10. Estimate life expectancy\<6 months
11. HIV infection
12. Chronic active hepatitis secondary to HCV or HBV (HBSAq positive)
13. 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

Primary outcomes:
measure: To assess the activity of decitabine in the treatment of CMML
timeFrame: 24 months
Secondary outcomes:
measure: 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
timeFrame: 24 months
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Ematologia, Ospedale SS Antonio e Biagio e Cesare Arrigo
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti di Ancona
city: Bari
country: Italy
facility: Ematologia AOU Policlinico di Bari
city: Bologna
country: Italy
facility: Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola
city: Brescia
country: Italy
facility: Ematologia - Spedali Civili
city: Cagliari
country: Italy
facility: Ematologia- Ospedale Businco
city: Campobasso
country: Italy
facility: Centro di ricerca e formazione ad alta tecnologia nelle Scienze, Università Cattolica
city: Firenze
country: Italy
facility: Cattedra di Ematologia Policlino Careggi
city: Genova
country: Italy
facility: Dipartimento Emato-Oncologia AOU San Martino Genova
city: Milano
country: Italy
facility: Fondazione IRCCS Caà Granda-Ospedale Maggiore policlinico
city: Monza
country: Italy
facility: Divisione di Ematologia, Ospedale S.Gerardo di Monza
city: Novara
country: Italy
facility: Divisione di Ematologia, Università Avogadro
city: Orbassano
country: Italy
facility: Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Perugia
country: Italy
facility: Ospedale S.Maria della Misericordia
city: Pesaro
country: Italy
facility: AOU San Salvatore
city: Reggio Calabria
country: Italy
facility: AO Bianchi Melacrino Morelli
city: Rionero in Vulture
country: Italy
facility: IRCCS Centri di riferimento oncologico
city: Roma
country: Italy
facility: SC Ematologia AOU S.Andrea
city: Torino
country: Italy
facility: Ematologia 2-Ospedale S.Giovanni Battista
city: Torino
country: Italy
facility: U.O.Ematologia 2
Study officials:
affiliation: U.O di Ematologia, AO of Careggi, viale Morgagni n.85-50134-Firenze
name: Santini Valeria, Professor
role: PRINCIPAL_INVESTIGATOR
References: