Multicenter Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia

Chronic Myelomonocytic Leukemia Clinical Trial

— DECI2009  

Official title:

A Phase II Multicenter Open-label Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251627
• Other study ID #: DECI2009-AISSM06
• Status: Completed
• Phase: Phase 2
• Start date: April 2010
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: Fondazione Italiana Sindromi Mielodisplastiche Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2018
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myelomonocytic Leukemia
• Leukemia
• Leukemia, Myelomonocytic, Acute
• Leukemia, Myelomonocytic, Chronic
• Leukemia, Myelomonocytic, Juvenile

Intervention

Drug:
• Decitabine
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.

Locations

Country	Name	City	State
Italy	Ematologia, Ospedale SS Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	AOU Ospedali Riuniti di Ancona	Ancona
Italy	Ematologia AOU Policlinico di Bari	Bari
Italy	Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola	Bologna
Italy	Ematologia - Spedali Civili	Brescia
Italy	Ematologia- Ospedale Businco	Cagliari
Italy	Centro di ricerca e formazione ad alta tecnologia nelle Scienze, Università Cattolica	Campobasso
Italy	Cattedra di Ematologia Policlino Careggi	Firenze
Italy	Dipartimento Emato-Oncologia AOU San Martino Genova	Genova
Italy	Fondazione IRCCS Caà Granda-Ospedale Maggiore policlinico	Milano
Italy	Divisione di Ematologia, Ospedale S.Gerardo di Monza	Monza
Italy	Divisione di Ematologia, Università Avogadro	Novara
Italy	Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga	Orbassano
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Ospedale S.Maria della Misericordia	Perugia
Italy	AOU San Salvatore	Pesaro
Italy	AO Bianchi Melacrino Morelli	Reggio Calabria
Italy	IRCCS Centri di riferimento oncologico	Rionero in Vulture
Italy	SC Ematologia AOU S.Andrea	Roma
Italy	Ematologia 2-Ospedale S.Giovanni Battista	Torino
Italy	U.O.Ematologia 2	Torino

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Italiana Sindromi Mielodisplastiche Onlus	Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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