Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT01342692
Eligibility Criteria:
Inclusion Criteria:
* age\>=18 years
* Must be able to adhere to the study visit schedule and other protocol requirements
* Documented diagnosis of MDS, including AREB-t according to FAB classification or CMML (with WBC \< 13,000/mm3) that meets IPSS criteria for intermediate-2 or high-risk.
* Patients should be willing to use adequate contraceptive methods during all the duration of the study
Exclusion Criteria:
1. Treatment with AZA or Decitabine in the previous 6 months
2. Previous treatment with any HDAC inhibitor (Sodium valproate, Vorinostat, depsipeptide ou NSC-630176, MS 275, LAQ-824, PXD-101, LBH589, MGCD0103, CRA024781, etc). If Sodium Valproate (Depakine®) was used for seizure, a wash-out period of at least 30 days is required and an appropriate treatment replacement should be performed.
3. Ongoing treatment with corticosteroids exceeding 30mg of prednisone per day. A wash out period of at least 7 days is required.
4. HIV infection
5. Creatinine \> 1.5 ULN
6. Serum AST or ALT \> 3.0 x upper limit of normal (ULN)
7. Serum total bilirubin \> 1.5 mg/dl (except for unconjugated hyperbilirubinemia due to Gilbert's disease or secondary to MDS).
8. ≥ grade-2 neuropathy
9. Previous history of Acute myeloblastic leukemia (with marrow blasts\>30%)
10. Previous history of allogeneic stem cell transplantation
11. Contra-indication to Anthracyclines: Myocardiopathy, uncontrolled infection, serious renal or hepatic impairment; associated with yellow fever vaccine
12. Known hypersensitivity to the active substance or to any of the excipients of Vidaza®, of valproate, of divalproate, of valpromide, of Lenalidomide, of thalidomide, of idarubicin and/or anthracyclines
13. Patients with a history of severe congestive heart failure, clinically unstable cardiac or pulmonary disease
14. All hepatitis or known personal or familial severe hepatitis, particularly due to drugs
15. Depression with suicidal tendency
16. Use of MILLEPERTUIS, mefloquine
17. No medical insurance in the French Health system
18. Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for ≥ 3 years.
19. Pregnant or lactating females
20. Eligibility for allogeneic stem cell transplantation
21. very altered general condition , with WHO performance status of 4, or life expectancy of less than 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01342692
Study Brief:
Protocol Section:
NCT01342692