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Study of Association of Arsenic Trioxide (ATO) and Ascorbic Acid in Myelodysplastic Syndromes

Information source: Fondazione Italiana Sindromi Mielodisplastiche Onlus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myelodysplastic Syndromes

Intervention: ATO + Ascorbic acid (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Fondazione Italiana Sindromi Mielodisplastiche Onlus

Official(s) and/or principal investigator(s):
Alessandro Levis, MD, Study Director, Affiliation: S.O.C. di Ematologia, Azienda Ospedaliera SS Antonio e Biagio, Alessandria. Via Venezia 18 - 15100 - Alessandria

Summary

This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of association of arsenic trioxide (ATO) and ascorbic acid in patients with myelodysplastic syndromes

Clinical Details

Official title: Phase II Multicenter Study of Association of Arsenic Trioxide (ATO) and Ascorbic Acid in Myelodysplastic Syndromes

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: TO evaluate the erythroid response rate (major), according to the International Working Group (IWG) criteria (42) after four months of treatment with the association of ATO and ascorbic acid.

Secondary outcome: To evaluate platelets and granulocyte response according to the International Working Group (IWG) criteria (42) after four months of treatment with the association of ATO and ascorbic acid

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients affected by myelodysplastic syndromes, entering in one of the following groups: 1. Myelodysplastic syndromes independent of WHO diagnostic classification (43) and IPSS prognostic score (2), when present at least one of the following abnormalities:

- 3q26 chromosome rearrangement.

- High EVI-1 transcript levels.

2. Myelodysplastic syndromes without excess of blasts (non-RAEB patients) at low or intermediate-1 score risk according to the IPSS (2), as a second line treatment option, after a failure to the first line treatment with erythropoietin +/- G-CSF, immunosuppressive therapy, or other initial treatment modality. 3. Non RAEB patients at intermediate-2 or high risk score or RAEB patients at any prognostic score, who are non candidate to treatment with conventional chemotherapy regimens. 2. Presence of one ore more cytopenias characterised by one ore more of the following elements:

- Transfusions dependence.

- Hb< 11 gr/dl

- Platelet count < 50x109/L

- Absolute neutrophil count < .5x109/L.

3. ECOG Performance status ≤ 2. 4. Aged from 18 to 80. 5. Life expectancy > 4 months. 6. Creatinine level < 1. 5 mg/dl. 7. Liver function tests, including ASL-ALT-alkaline phosphatase lower than 3xULN 8. No previous treatment with chemotherapy, growth factors, cytokines or other experimental treatment within 4 weeks of starting treatment. 9. No history of clinically significant cardiac disease, including congestive heart failure. 10. Cytogenetic evaluation available. 11. Sending of both peripheral blood and bone marrow sample to the central laboratory for EVI-1 rearrangement evaluation. 12. Written Informed consent. Exclusion Criteria: 1. Patients affected by myelodysplastic syndromes entering in categories other than those foreseen by inclusion criteria point 1. 2. Absence of cytopenia defined as the contemporarily presence of all the following conditions: a) no transfusion need; b) Hb > 11 gr/dl; c) platelet count > 50x109/L; d) absolute neutrophil count > .5x109/L. 3. All patients that might be candidate to allogenic stem cell transplantation. 4. Patients that might be candidate to a first line immunosuppressive therapy. 5. ECOG Performance status > 2. 6. Age lower than 18 or higher then 80. 7. Life expectancy < 4 months. 8. Creatinine level > 1. 5 mg/dl. 9. Liver function tests, including ASL-ALT-alkaline phosphatase higher than 3xULN 10. Treatment with chemotherapy, growth factors, cytokines or other experimental treatment within 4 weeks of starting treatment. 11. Clinically significant cardiac disease, including congestive heart failure, rhythm abnormalities, QT time > 460m/s, or need of anti-arrhythmic drugs. 12. Concurrent co-morbid medical condition which might exclude administration of therapy, as judged by individual investigator. 13. Absence of cytogenetic evaluation. 14. Participation at same time in another study in which investigational drugs are used. 15. Absence of written Informed consent.

Locations and Contacts

Ospedale SS Antonio, Biagio e Cesare Arrigo, Alessandria, Italy

Ospedale Cardinal Massaia, Asti, Italy

Spedali Civili, Brescia, Italy

Ospedale Maggiore, Chieri, Italy

Ospedale civico di Chivasso, Chivasso (TO), Italy

Ospedale Santa Croce e Carle, Cuneo, Italy

AOS San Gerardo de' Tintori, Monza, Italy

Università Avogadro Divisione di Ematologia, Novara, Italy

Ospedale San Luigi Gonzaga Divisione di Ematologia, Orbassano (TO), Italy

Azienda Ospedaliera Perugia, Perugia, Italy

Ospedale San Giovanbni Battista-Molinette, Torino, Italy

Ospedale San Giovanni Battista -Molinette, Torino, Italy

Ospedale San Bortolo, Vicenza, Italy

Additional Information

Starting date: September 2005
Last updated: June 27, 2011

Page last updated: August 23, 2015

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