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Completed

NCT Number: NCT01251627

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

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

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Key information

Conditions

Chronic Myelomonocytic Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ematologia, Ospedale SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 and older
  • CMML diagnosis according to WHO criteria
  • 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
  • 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
  • Performance Status ECOG 0,1 or 2
  • Estimated life expectancy>=6 months
  • 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
  • Adequate renal function:
  • Serum creatinine < 1.5 times limit of normal
  • Creatinine clearance > 30ml/min
  • Informed consent
  • Negative pregnancy test or adequate contraception methods

Exclusion criteria

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

Treatment and study plan

decitabine

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.

Primary outcomes

  1. To assess the activity of decitabine in the treatment of CMML

    Time frame: 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Sindromi Mielodisplastiche-ETS

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DECI2009

Important dates

Study start
2010
Primary completion
2011
Study completion
2018
First posted
Dec 2, 2010
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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