Decitabine in Patients With Chronic Myelomonocytic Leukemia (CMML)

Phase 2

Completed

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

• Registration Number: NCT01098084
• Lead Sponsor: Groupe Francophone des Myelodysplasies

Brief Summary

The aim of this study is to determine the therapeutic efficacy of Decitabine in patients with chronic myelomonocytic leukemia (CMML) diagnosis according to WHO criteria either untreated or previously treated with Hydrea or Etoposide (given orally), non intensive chemotherapy or intensive chemotherapy given more than 3 months before inclusion.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2010-04-01
• Study First Submitted QC: 2010-04-01
• Study First Posted: 2010-04-02
• Status Verified: 2011-03
• Last Update Submitted: 2014-03-19
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Age 18 or older

• CMML diagnosis according to WHO criteria

• Stable excess in blood monocytes,>1x10G/l and >10% of WBC

• Bone marrow blasts <20%

• Dysplasia of at least one lineage or clonality marker or blood monocytosis during more than 3 months w/o other explanation

• With:

  • if WBC < or= 12 000/mm3: IPSS high or intermediate 2
  • if WBC > 12 000/mm3: at least two of the following criteria: blast cells > 5% in the bone marrow, clonal cytogenetic abnormality other than t(5;12)(q33;p13), anemia (Hb < 100 g/l), thrombocytopenia (platelet count < 100G/l), splenomegaly > 5 cm below costal margin, extramedullary localization

• Either untreated or previously treated with

• Hydrea or Etoposide given orally

• non intensive chemotherapy

• intensive chemotherapy given more than 3 months before inclusion

• With performance status 0-2 on the ECOG scale

• With estimated life expectancy of at least 12 weeks

• With adequate organ function including the following:

  • Hepatic: total bilirubin < 1.5 times upper limit of normal (ULN), alanine transaminase (ALT) and aspartate transaminase (AST) < 3 times ULN
  • Renal: serum creatinine < 1.5 times ULN, creatinine clearance > 30 ml/min

• With informed consent

• Negative pregnancy and adequate contraception if relevant

Exclusion Criteria

• Myeloproliferative/myelodysplastic syndrome other than CMML
• Acute blastic transformation of CMML with bone marrow blasts>20%
• Patients eligible for allogenic bone marrow transplantation with identified donor
• CMML with t(5;12) or PDGFbetaR rearrangement that could receive Imatinib
• Previous treatment with a hypomethylating agent
• Age < 18 years old
• Pregnancy or breastfeeding
• Performance status> 2 on the ECOG Scale
• Estimated life expectancy < 12 weeks
• Serious concomitant systemic disorder, 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	-

Primary Outcome Measures

Name	Time	Method
To determine response of patients with CMML to 6 courses of Decitabine according to IWG 2006 criteria, adapted for CMML with WBC>12000/mm3

Secondary Outcome Measures

Name	Time	Method
Toxicity (hematological and non-hematological)
Response duration
Time to progression to AML
Survival

Trial Locations

Locations (31)

CH Angers; 🇫🇷 Angers, France

Hôpital Avicenne; 🇫🇷 Bobigny, France

CHU de Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, Ile de France, France

Centre Hospitalier du Mans; 🇫🇷 Le Mans cedex, France

CHU de nantes; 🇫🇷 Nantes, France

CHU Haut-Lévèque; 🇫🇷 Bordeaux, France

Hôpital Boulogne Sur Mer; 🇫🇷 Boulogne Sur Mer, France

Hopital d'Instruction des Armées Percy; 🇫🇷 Clamart, France

CHU de; 🇫🇷 Clermont Ferrand, France

Centre Hospitalier Sud-Francilien; 🇫🇷 Corbeil-Essonnes, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Hôpital Archet1; 🇫🇷 Nice, France

Hopital Henri Mondor; 🇫🇷 Creteil, France

Hôpital Versailles; 🇫🇷 Le Chesnay, France

Hôpital Saint-Antoine.; 🇫🇷 Paris-Cedex 12, France

CHU de Dijon; 🇫🇷 Dijon, France

CHR La Source orléans; 🇫🇷 Orléans, France

Hopital Cochin; 🇫🇷 Paris, France

Hopital Hotel Dieu; 🇫🇷 Paris, France

Centre Hospitalier Joffre; 🇫🇷 Perpignan, France

Hoiptal St Louis; 🇫🇷 Paris, France

CHU de Reims; 🇫🇷 Reims, France

Hematology Dpt, Hopital Purpan; 🇫🇷 Toulouse, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

CHU Bretoneau; 🇫🇷 Tours, France

Institut gustave Roussy; 🇫🇷 Villejuif, France

Hôpital Avignon; 🇫🇷 Avignon, France

CHU d'Amiens; 🇫🇷 Amiens, France

Hopital de la Cote Basque; 🇫🇷 Bayonne, France

CHU Caremeau; 🇫🇷 Nimes, France

Hopital Necker; 🇫🇷 Paris, France