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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT01718366
Eligibility Criteria:
Inclusion Criteria:
* High risk MDS, according to OMS classification
* High risk CMML (WBC \< 13 G/L)
* AREBT of the FAB classification with less than 30% of blastes
* IPSS\>=1.5 (int-2 and high risk)
* Age \>=18y
* Performance status\<=2 (ECOG)
* Bilirubin and transaminase \< 1.5 x ULN
* Normal renal function
* Patient not eligible for Allogeneic stem cell transplant
* Male and female patients must use an effective contraceptive method during the study and for a minimum of 3 months after study treatment.
* Agree the need for the use of a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential. during the entire period of treatment, even if disruption of treatment and during 3 months after end of treatment
* Male patient: Agree not to conceive during treatment and study drug therapy (including doses interruptions) and for 3 months after the end of the study drug therapy
* Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
* Agree to learn about the procedures for preservation of sperm,before starting treatment
* Patient be able to adhere to the study visit schedule and other protocol requirements
Exclusion Criteria:
* Active infection or uncontrolled disease
* Use of cytotoxic chemotherapeutic agents or experimental agents(agents that are not commercially available) for the treatment of MDS within 28 days. In case of used of cytotoxic chemotherapeutic agents or hypomethylating agent a wash out of 3 mont is required.
* Active Cancer or Cancer within one year before inclusion
* Previous calcic urinary lithiasis
* Previous hyperparathyroid primitive disease or uncontrolled
* Hypercalcemia, hyperphosphoremia, hypervitaminosis D
* Patient already include in another experimental study
* Active infection by HIV, hepatite B or C
* Pregnant or lactating females
* Patient not able (medical/psychiatric) to understand and sign the written consent
* Patients with a ferritin level less than 300ng/ml
* Patient eligible for an Allogeneic stem cell transplant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01718366
Study Brief:
Protocol Section:
NCT01718366