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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT01063257
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 years or more with MDS according to FAB classification and intermediate-2 or high IPSS risk scores, or CMML (with WBC \< 13 x 109/L and bone marrow blasts \> 10 %) according to WHO classification, or AML according to WHO classification if less than 30 % bone marrow blasts (RAEB-T according to FAB MDS classification or AML according to WHO classification with more than 30 % with bone marrow blasts only if preceded by a proven MDS phase.
* Patients previously treated by azacitidine (Vidaza®) in proven progression, or stable after 6 courses with ongoing transfusion dependent anemia (\> 4 RBC units in the 8 weeks preceding inclusion (as erythroid response in IWG 2006 criteria is reduction of at least 4 RBC units in 8 weeks).
* Previous biological and or targeted therapies of MDS or AML are allowed if stopped more than 1 month before inclusion.
* ECOG PS ≤ 2.
* Adequate renal and liver function :
i.e. Serum creatinine \< 110 microM in men or 90 microM in women. If plasma creatinine level \< 90 - 110 microM, then the estimated glomerular filtration rate (GFR) must be \< 50 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation where Predicted GFR (mL/min/1.73 m2) = 32788 x (plasma creatinine level (microM)-1.154 x (age in years)-0.023 x (0.742 if patient is female) x (1.212 if patient is African American)
* Bilirubin \< 1.5 x ULN, (except increased unconjugated bilirubin due to dyserythropoiesis).
* Aspartate transaminase (AST)/alanine transaminase (ALT) \< 2.5 × ULN and Alkaline phosphatase \< 2.5 × ULN.
* Absence of pregnancy or lactation in female patients (Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment).
* Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
* Provided signed written informed consent.
* Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
Exclusion Criteria:
* Patients with AML and bone marrow blasts count of 20-30%, if candidates to intensive AML type chemotherapy.
* Known hypersensitivity to clofarabine or excipients.
* Concomitant malignant disease.
* Active uncontrolled infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
* Concomitant severe cardiovascular disease, i.e. congestive heart failure (NYHA grade \> 3).
* Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
* No affiliation to a national insurance scheme directly or to an equivalent system.
* Chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
* Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute toxicities from any previous therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01063257
Study Brief:
Protocol Section:
NCT01063257