Study of Association of Arsenic Trioxide (ATO) and Ascorbic Acid in Myelodysplastic Syndromes
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ClinicalTrials.gov Identifier: NCT00803530 |
Recruitment Status :
Terminated
(difficulties of enrollement)
First Posted : December 5, 2008
Last Update Posted : June 28, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myelodysplastic Syndromes | Drug: ATO + Ascorbic acid | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 55 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Multicenter Study of Association of Arsenic Trioxide (ATO) and Ascorbic Acid in Myelodysplastic Syndromes |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | January 2007 |
Actual Study Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Loading phase (week 1): ATO 0.3 mg/Kg/die for 5 consecutive days.
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Drug: ATO + Ascorbic acid
ATO will be diluted in 250 ml of normal saline solution at a dosage of 0.3 mg/Kg during the first week of therapy and at a dosage of 0.25 mg/Kg during the subsequent weeks (week 2 to 16), and administered intravenously over a 1-2 hour period. The dose of ascorbic acid will be 1000 mg in 100 cc D5W or normal saline solution (NaCl 0.9 %) (protected from light and air) administered as an IV infusion over 15 to 30 minutes. The dosing solution is not to be mixed with any alkaline solution. |
- 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. [ Time Frame: 16 mounths ]
- 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 [ Time Frame: 16 mounths ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Patients affected by myelodysplastic syndromes, entering in one of the following groups:
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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.
- 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.
- 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.
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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.
- ECOG Performance status ≤ 2.
- Aged from 18 to 80.
- Life expectancy > 4 months.
- Creatinine level < 1.5 mg/dl.
- Liver function tests, including ASL-ALT-alkaline phosphatase lower than 3xULN
- No previous treatment with chemotherapy, growth factors, cytokines or other experimental treatment within 4 weeks of starting treatment.
- No history of clinically significant cardiac disease, including congestive heart failure.
- Cytogenetic evaluation available.
- Sending of both peripheral blood and bone marrow sample to the central laboratory for EVI-1 rearrangement evaluation.
- Written Informed consent.
Exclusion Criteria:
- Patients affected by myelodysplastic syndromes entering in categories other than those foreseen by inclusion criteria point 1.
- 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.
- All patients that might be candidate to allogenic stem cell transplantation.
- Patients that might be candidate to a first line immunosuppressive therapy.
- ECOG Performance status > 2.
- Age lower than 18 or higher then 80.
- Life expectancy < 4 months.
- Creatinine level > 1.5 mg/dl.
- Liver function tests, including ASL-ALT-alkaline phosphatase higher than 3xULN
- Treatment with chemotherapy, growth factors, cytokines or other experimental treatment within 4 weeks of starting treatment.
- Clinically significant cardiac disease, including congestive heart failure, rhythm abnormalities, QT time > 460m/s, or need of anti-arrhythmic drugs.
- Concurrent co-morbid medical condition which might exclude administration of therapy, as judged by individual investigator.
- Absence of cytogenetic evaluation.
- Participation at same time in another study in which investigational drugs are used.
- Absence of written Informed consent.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803530
Italy | |
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 |
Study Director: | Alessandro Levis, MD | S.O.C. di Ematologia, Azienda Ospedaliera SS Antonio e Biagio, Alessandria. Via Venezia 18 - 15100 - Alessandria |
Responsible Party: | Alessandro Levis, Azienda Ospedaliera SS Antonio e Biagio, Alessandria. |
ClinicalTrials.gov Identifier: | NCT00803530 |
Other Study ID Numbers: |
AISSM02A EudracT Number 2005-001321-28 |
First Posted: | December 5, 2008 Key Record Dates |
Last Update Posted: | June 28, 2011 |
Last Verified: | June 2011 |
myelodysplastic syndromes arsenic trioxide ascorbic acid |
Preleukemia Myelodysplastic Syndromes Syndrome Disease Pathologic Processes Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms |
Ascorbic Acid Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Nutrients Growth Substances |