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

NCT ID: NCT01251627

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2018-06-30

Brief Summary

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

Conditions

Chronic Myelomonocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Decitabine

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.

Group Type: EXPERIMENTAL

Decitabine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

OTHER

Sponsor Role: collaborator

Fondazione Italiana Sindromi Mielodisplastiche-ETS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Santini Valeria, Professor

Role: PRINCIPAL_INVESTIGATOR

U.O di Ematologia, AO of Careggi, viale Morgagni n.85-50134-Firenze

Locations

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

Florence, , Italy

Dipartimento Emato-Oncologia AOU San Martino Genova

Genova, , Italy

Fondazione IRCCS Caà Granda-Ospedale Maggiore policlinico

Milan, , 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

Padua, , 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, , Italy

Countries

Italy

Other Identifiers

DECI2009-AISSM06

Identifier Type: -

Identifier Source: org_study_id