Last updated on July 2017

A Study of Combined Deferasirox Vitamin D and Azacytidine in High Risk MDS


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: MDS
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    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
    tudy 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

You may not be eligible for this study if the following are true:

  • 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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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