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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT01305135
Eligibility Criteria:
Inclusion Criteria:
* Documented diagnosis of MDS, or CMML with WBC \< 13,000/mm3 that meets IPSS criteria for intermediate-2 or high-risk disease,
* IPSS score ≥1.5
* Myocardial function do not contraindicate the use of idarubicin
* Age ≥ 18 years
* Performance Status ≤2 according to ECOG.
* Serum creatinine \< 1.5 x ULN and normal levels of electrolytes (serum sodium 136-145 mmol/l, Potassium 3,5-4,5 mmol/l, alkaline Reserve 23-29 mmol/l, , Calcium 2,15-2,5 mmol/l, Phosphore 0,87-1,45 mmol/l) Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) \< 1.5 x upper limit of normal (ULN)
* Serum total bilirubin \< 1.5 x ULN.
* Must be able to adhere to the study visit schedule and other protocol requirements
* Signed informed consent.
Female subjects of childbearing potential must:
• Accept effective contraception without interruption throughout the duration of study and up to three months after the end of treatment.
Male subjects must
* Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy and up to three months after the final treatment if their partner is of childbearing potential and has no contraception.
* Agree to learn the procedures for preservation of sperm
Exclusion Criteria:
* Uncontrolled infection
* Prior therapy with anthracycline for MDS.
* Eligible for an allogeneic stem cell transplantation.
* Prior therapy with demethylating agents within the last 3 months
* Prior therapy with Hematopoietic growth factor (ESA or G-CSF) agents or cytotoxic agents (oral chemotherapy, low doses AraC) within the last 30 days.
* Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast)
* Pregnant or lactating females
* Known HIV-1 positivity
* Contra-indication to Anthracyclines
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01305135
Study Brief:
Protocol Section:
NCT01305135