A Phase II study of Decitabine in patients with Chronic Myelomonocytic Leukemia - GFM-DEC-LMMC-2007-02

• Conditions: Chronic Myelomonocytic Leukemia; MedDRA version: 9.1Level: LLTClassification code 10009018Term: Chronic myelomonocytic leukaemia

• Registration Number: EUCTR2008-000470-21-FR
• Lead Sponsor: Groupe Francophone des Myélodysplasies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients aged 18 and older

With CMML diagnosis according to WHO criteria

-Stable excess in blood monocytes, > 1 x 109/L and constituting > 10% WBC

- Lack of bcr-abl rearrangement (or Philadelphia chromosome)

- Bone marrow blast cells < 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 <12 000/mm3 : IPSS high or intermediate 2

If WBC > or = 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 < 100 x 109/L)
-Splenomegaly > 5 cm below costal margin
-Extramedullary localization (documented cutaneous, pleural or pericardial effusion, etc…)

Either untreated or previously treated with
-Hydrea or Etoposide given orally
-Non intensive chemotherapy (e.g. low dose cytarabine)
-Intensive chemotherapy given more than 3 months before inclusion

With performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale.

With estimated life expectancy of at least 12 weeks (this is inherent to ECOG 0-2, and actually very hard to predict/verify, therefore we prefer to take this out)

With adequate organe function including the following
-Hepatic : total bilirubin < 1.5 times upper limit of normal (ULN) (except moderate unconjugated hyperbilirubinemia due to intra medullary hemolysis) , 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

With negative pregnancy and adequate contraception if relevant.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Myeloproliferative / myelodysplastic syndrome other than CMML

-Acute blastic transformation of CMML with bone marrow blast cells > 20%

-Patients eligible for allogeneic bone marrow transplantation with a identified donor

-CMML with t(5 ;12) or PDGF?R rearrangement that could receive imatinib

-Intensive chemotherapy given within 3 months

-Previous treatment with a hypomethylating agent

-Age < 18

-Pregnant or breastfeeding

-Performance status > 2 on the ECOG Scale.

-Estimated life expectancy lower than 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.

-Consent withdrawal

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified