Multicenter Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia (DECI2009)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Information provided by (Responsible Party):
Fondazione Italiana Sindromi Mielodisplastiche Onlus
ClinicalTrials.gov Identifier:
NCT01251627
First received: December 1, 2010
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Chronic Myelomonocytic Leukemia
Drug: Decitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Multicenter Open-label Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Fondazione Italiana Sindromi Mielodisplastiche Onlus:

Primary Outcome Measures:
  • To assess the activity of decitabine in the treatment of CMML [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 41
Study Start Date: April 2010
Estimated Study Completion Date: March 2014
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251627

Locations
Italy
Ematologia, Ospedale SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy, 15121
AOU Ospedali Riuniti di Ancona
Ancona, Italy, 60131
Ematologia AOU Policlinico di Bari
Bari, Italy, 70124
Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola
Bologna, Italy, 40100
Ematologia - Spedali Civili
Brescia, Italy, 25100
Ematologia- Ospedale Businco
Cagliari, Italy, 09121
Centro di ricerca e formazione ad alta tecnologia nelle Scienze, Università Cattolica
Campobasso, Italy, 86100
Cattedra di Ematologia Policlino Careggi
Firenze, Italy, 50134
Dipartimento Emato-Oncologia AOU San Martino Genova
Genova, Italy, 16132
Fondazione IRCCS Caà Granda-Ospedale Maggiore policlinico
Milano, Italy, 20121
Divisione di Ematologia, Ospedale S.Gerardo di Monza
Monza, Italy, 20052
Divisione di Ematologia, Università Avogadro
Novara, Italy, 28100
Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga
Orbassano, Italy, 10043
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Ospedale S.Maria della Misericordia
Perugia, Italy, 06122
AOU San Salvatore
Pesaro, Italy, 61122
AO Bianchi Melacrino Morelli
Reggio Calabria, Italy, 89125
IRCCS Centri di riferimento oncologico
Rionero in Vulture, Italy, 85028
SC Ematologia AOU S.Andrea
Roma, Italy, 00183
Ematologia 2-Ospedale S.Giovanni Battista
Torino, Italy, 10126
U.O.Ematologia 2
Torino, Italy, 10126
Sponsors and Collaborators
Fondazione Italiana Sindromi Mielodisplastiche Onlus
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Investigators
Principal Investigator: Santini Valeria, Professor U.O di Ematologia, AO of Careggi, viale Morgagni n.85-50134-Firenze
  More Information

No publications provided

Responsible Party: Fondazione Italiana Sindromi Mielodisplastiche Onlus
ClinicalTrials.gov Identifier: NCT01251627     History of Changes
Other Study ID Numbers: DECI2009-AISSM06
Study First Received: December 1, 2010
Last Updated: September 30, 2013
Health Authority: Italy: National Monitoring Center for Clinical Trials-Ministery Health

Keywords provided by Fondazione Italiana Sindromi Mielodisplastiche Onlus:
Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Decitabine

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014