Phase II Clinical Trial for Treatment of Myelodysplastic Syndromes Comparing Hydralazine / Ac.Valproico and Supportive Care in Patients Not Candidates, Refractory and / or Intolerant to Intensive Chemotherapy
1. Ability to understand and voluntarily sign the consent form.
2. Age ≥ 18 years at the time of signing the informed consent form.
3. Ability and willingness to meet the schedule of study visits and other protocol
4. Documented diagnosis of SMDs according to the criteria of disease risk IPSS
intermediate-2, high risk or any risk with transfusion requirements.
5. Transfusion-dependent anemia erythrocytes defined as the absence of a period of 56
consecutive days without transfusion of red blood cells for at least 112 days prior
6. Engage both women and men to use highly effective contraception.
7. Patients are not candidates for treatment with azacitidine or chemotherapy
- Patients who have any of these exclusion criteria may not be included in the trial:
1. Pregnant or breastfeeding.
2. After hematopoietic stem cell transplantation.
3. Patients with vitamin B12 deficiency, Folic Acid and Iron
4. Any severe psychiatric illness or condition that prevents the patient sign the
consent form for the patient or involves an unacceptable risk in case of
participating in the study.
5. Hypersensitivity to hydralazine and / or AC. Valproic