Decitabine in Patients With Chronic Myelomonocytic Leukemia (CMML)

Chronic Myelomonocytic Leukemia Clinical Trial

Official title:

A Phase II Study of Decitabine in Patients With Chronic Myelomonocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098084
• Other study ID #: GFM-DEC-LMMC-2007
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2010
• Last updated: March 19, 2014
• Start date: November 2008
• Est. completion date: June 2009

Study information

• Verified date: March 2011
• Source: Groupe Francophone des Myelodysplasies
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : ANSM agence nationale de sécurité du médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment

Related Conditions & MeSH terms

• Chronic Myelomonocytic Leukemia
• Leukemia
• Leukemia, Myelomonocytic, Acute
• Leukemia, Myelomonocytic, Chronic

Intervention

Drug:
• Decitabine
20mg/m2/day, one hour intravenous infusion, every day during 5 days

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens
France	CH Angers	Angers
France	Hôpital Avignon	Avignon
France	Hopital de la Cote Basque	Bayonne
France	Hôpital Avicenne	Bobigny
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	Hopital Henri Mondor	Creteil
France	CHU de Dijon	Dijon
France	Hôpital Versailles	Le Chesnay
France	CHU de Bicêtre	Le Kremlin-Bicêtre	Ile de France
France	Centre Hospitalier du Mans	Le Mans cedex
France	Institut Paoli Calmettes	Marseille
France	CHU de nantes	Nantes
France	Hôpital Archet1	Nice
France	CHU Caremeau	Nimes
France	CHR La Source orléans	Orléans
France	Hoiptal St Louis	Paris
France	Hopital Cochin	Paris
France	Hopital Hotel Dieu	Paris
France	Hopital Necker	Paris
France	Hôpital Saint-Antoine.	Paris-Cedex 12
France	Centre Hospitalier Joffre	Perpignan
France	CHU de Reims	Reims
France	Centre Henri Becquerel	Rouen
France	Hematology Dpt, Hopital Purpan	Toulouse
France	CHU Bretoneau	Tours
France	Institut gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Francophone des Myelodysplasies	Janssen-Cilag Ltd.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Response duration
Secondary	Time to progression to AML
Secondary	Survival
Secondary	Toxicity (hematological and non-hematological)