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Comparison Between Erythropoietin and Erythropoietin Associated to Differentiating Therapy With Acid 13-cis-retinoic and Dihydroxyvitamin D3 in Myelodysplastic Syndromes Without Excess of Blasts


Phase 3
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

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Trial Information

Comparison Between Erythropoietin and Erythropoietin Associated to Differentiating Therapy With Acid 13-cis-retinoic and Dihydroxyvitamin D3 in Myelodysplastic Syndromes Without Excess of Blasts


Inclusion Criteria:



1. Age higher than 18;

2. Confirmed diagnosis by osseous biopsy and bone marrow cyto-morphologic counts of
blast cells, of Myelodysplastic syndrome without excess of blasts: "refractary
anemia", "refractary anemia with rings sideroblasts", "refractary citopenya with
multilineage dysplasia", " refractary citopenya with multilineage dysplasia and rings
sideroblasts" or "5q-syndrome" without excess of blasts based on WHO classification
(appendix).

3. Low or intermediate-1 IPSS (appendix).

4. Hb < 11g/dl.

5. rEPO serum level < 500mU/L.

6. Women in menopause from at least one year.

7. Informed consent

Exclusion Criteria:

1. Myelodisplastic syndrome with excess of blasts (RAEB).

2. IPSS score intermediate-2 or high (appendix).

3. Forecasted allogeneic bone marrow transplant within 1 year after diagnosis(patients
younger than 60 years, transfusion dependents or with serious leuko/thrombocytopenia
and HLA compatible family donor).Considering the time needed to perform this
procedure, the indication of a transplant from non-consanguineous donor has no
contraindication to the inclusion in this protocol of the response to rEPO therapy ±
differentiating therapy.

4. Renal failure with creatininemia value greater than 3 times the normal limit.

5. Chronic hepatophaty with bilirubinemia value greater than 3 times the normal limit
and/or AST or ALT or ALP values greater than 5 times the normal limit.

6. Presence of second tumor or other serious pathology with life expectancy lower than
one year.

7. Presence of neurologic or psychiatric pathologies that make the patient unreliable in
the acquisition of drugs.

8. Allergy/intolerance known to use drugs.

9. Pregnant women.

10. Women of childbearing age or in menopause from less than one year.

11. Age < 18 years old.

12. HIV positive.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

study of comparison between standard theraphy rEPO (40.000unit/week) and association therapy between rEPO (40.000unit/week)plus Acid 13-Cis-Retinoic and Dihydroxyvitamin D3

Outcome Time Frame:

After 8 months

Safety Issue:

Yes

Principal Investigator

Dario Ferrero, MD

Investigator Role:

Study Director

Investigator Affiliation:

University of Torino - Ospedale San Giovanni Battista

Authority:

Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

EPO2006-AISSM04

NCT ID:

NCT00804050

Start Date:

March 2007

Completion Date:

March 2010

Related Keywords:

  • Myelodysplastic Syndromes
  • Myelodysplastic Syndromes
  • Erythropoietin
  • Acid 13-Cis-Retinoic
  • Dihydroxyvitamin D3
  • low or intermediate-1 IPSS
  • MDS low risk
  • Myelodysplastic Syndromes
  • Preleukemia

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