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

Phase 2

Completed

• Conditions: Chronic Myelomonocytic Leukemia
• Interventions: Drug: Decitabine

• Registration Number: NCT01251627
• Lead Sponsor: Fondazione Italiana Sindromi Mielodisplastiche-ETS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-02
• Primary Completion: 2011-12
• Status Verified: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Decitabine	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.

Primary Outcome Measures

Name	Time	Method
To assess the activity of decitabine in the treatment of CMML	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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (21)

Divisione di Ematologia, Ospedale S.Gerardo di Monza; 🇮🇹 Monza, Italy

Ospedale S.Maria della Misericordia; 🇮🇹 Perugia, 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

Centro di ricerca e formazione ad alta tecnologia nelle Scienze, Università Cattolica; 🇮🇹 Campobasso, Italy

Divisione di Ematologia, Università Avogadro; 🇮🇹 Novara, Italy

Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga; 🇮🇹 Orbassano, Italy

AO Bianchi Melacrino Morelli; 🇮🇹 Reggio Calabria, Italy

U.O.Ematologia 2; 🇮🇹 Torino, Italy

Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola; 🇮🇹 Bologna, Italy

SC Ematologia AOU S.Andrea; 🇮🇹 Roma, Italy

Ematologia- Ospedale Businco; 🇮🇹 Cagliari, Italy

Dipartimento Emato-Oncologia AOU San Martino Genova; 🇮🇹 Genova, Italy

Ematologia 2-Ospedale S.Giovanni Battista; 🇮🇹 Torino, Italy

Ematologia - Spedali Civili; 🇮🇹 Brescia, Italy

Cattedra di Ematologia Policlino Careggi; 🇮🇹 Firenze, Italy

Fondazione IRCCS Caà Granda-Ospedale Maggiore policlinico; 🇮🇹 Milano, Italy

AOU San Salvatore; 🇮🇹 Pesaro, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

IRCCS Centri di riferimento oncologico; 🇮🇹 Rionero in Vulture, Italy