Decitabine in Patients With Chronic Myelomonocytic Leukemia (CMML)

NCT01098084 | Completed Phase 2 DMC

• 1 other identifier: GFM-DEC-LMMC-2007
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 31

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.

Conditions

Chronic Myelomonocytic Leukemia

Keywords

Decitabine, chronic myelomonocytic leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Response duration

• Time to progression to AML

• Survival

• Toxicity (hematological and non-hematological)

Study Arms (1)

Decitabine

EXPERIMENTAL

Drug: Decitabine

Interventions

Decitabine DRUG

20mg/m2/day, one hour intravenous infusion, every day during 5 days

Decitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Francophone des Myelodysplasies: lead
• Janssen-Cilag Ltd.: collaborator

Study Sites (31)

CHR La Source orléans

Orléans, Orléans, 45067, France

Location

CHU d'Amiens

Amiens, 80054, France

Location

CH Angers

Angers, 49 000, France

Location

Hôpital Avignon

Avignon, 84000, France

Location

Hopital de la Cote Basque

Bayonne, 64100, France

Location

Hôpital Avicenne

Bobigny, 93009, France

Location

CHU Haut-Lévèque

Bordeaux, 33604, France

Location

Hôpital Boulogne Sur Mer

Boulogne-sur-Mer, 62321, France

Location

Hopital d'Instruction des Armées Percy

Clamart, 92140, France

Location

CHU de

Clermont-Ferrand, 63058, France

Location

Centre Hospitalier Sud-Francilien

Corbeil-Essonnes, 91106, France

Location

Hopital Henri Mondor

Créteil, 94000, France

Location

CHU de Dijon

Dijon, 21034, France

Location

Hôpital Versailles

Le Chesnay, 78157, France

Location

Centre Hospitalier du Mans

Le Mans, 72037, France

Location

Institut Paoli Calmettes

Marseille, 13009, France

Location

CHU de nantes

Nantes, 44093, France

Location

Hôpital Archet1

Nice, 06202, France

Location

CHU Caremeau

Nîmes, 30029, France

Location

Hopital Cochin

Paris, 75014, France

Location

Hopital Necker

Paris, 75015, France

Location

Hopital Hotel Dieu

Paris, 75181, France

Location

Hoiptal St Louis

Paris, 75475, France

Location

Hôpital Saint-Antoine.

Paris, 75571, France

Location

Centre Hospitalier Joffre

Perpignan, 66046, France

Location

CHU de Reims

Reims, 51092, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Hematology Dpt, Hopital Purpan

Toulouse, 40031, France

Location

CHU Bretoneau

Tours, 37044, France

Location

Institut gustave Roussy

Villejuif, 94805, France

Location

CHU de Bicêtre

Le Kremlin-Bicêtre, Île-de-France Region, 94275, France

Location

Related Publications (2)

• Itzykson R, Kosmider O, Renneville A, Gelsi-Boyer V, Meggendorfer M, Morabito M, Berthon C, Ades L, Fenaux P, Beyne-Rauzy O, Vey N, Braun T, Haferlach T, Dreyfus F, Cross NC, Preudhomme C, Bernard OA, Fontenay M, Vainchenker W, Schnittger S, Birnbaum D, Droin N, Solary E. Prognostic score including gene mutations in chronic myelomonocytic leukemia. J Clin Oncol. 2013 Jul 1;31(19):2428-36. doi: 10.1200/JCO.2012.47.3314. Epub 2013 May 20.

  PMID: 23690417 DERIVED

• Braun T, Itzykson R, Renneville A, de Renzis B, Dreyfus F, Laribi K, Bouabdallah K, Vey N, Toma A, Recher C, Royer B, Joly B, Vekhoff A, Lafon I, Sanhes L, Meurice G, Orear C, Preudhomme C, Gardin C, Ades L, Fontenay M, Fenaux P, Droin N, Solary E; Groupe Francophone des Myelodysplasies. Molecular predictors of response to decitabine in advanced chronic myelomonocytic leukemia: a phase 2 trial. Blood. 2011 Oct 6;118(14):3824-31. doi: 10.1182/blood-2011-05-352039. Epub 2011 Aug 9.

  PMID: 21828134 DERIVED

MeSH Terms

Conditions

Leukemia, Myelomonocytic, Chronic

Interventions

Decitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Eric Solary, MD, PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

• Thorsten Braun, MD,PhD

  Avicenne Hospital, 93 000 Bobigny

  PRINCIPAL INVESTIGATOR

• Ingrid Lafon, MD

  CHU Le Bocage, Dijon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 2, 2010
• Study Start: November 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 20, 2014

Record last verified: 2011-03

Locations

FR (31)