AzTrials
AzTrials

Myelodysplastic SyndromesPhase 2NCT00803530

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

A Phase 2 study testing ATO + Ascorbic acid in people with Myelodysplastic Syndromes, run by Fondazione Italiana Sindromi Mielodisplastiche-ETS at 13 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Myelodysplastic Syndromes
What is being tested?
ATO + Ascorbic acid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
13 sitesItaly
Study dates
Sep 2005to Aug 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients affected by myelodysplastic syndromes, entering in one of the following groups:
  • 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.
Show all 21Show fewer
  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Italy13 sites

  • Ospedale SS Antonio, Biagio e Cesare Arrigo

    Alessandria

  • Ospedale Cardinal Massaia

    Asti

  • Spedali Civili

    Brescia

  • Ospedale Maggiore

    Chieri

  • Ospedale civico di Chivasso

    Chivasso (TO)

  • Ospedale Santa Croce e Carle

    Cuneo

  • AOS San Gerardo de' Tintori

    Monza

  • Università Avogadro Divisione di Ematologia

    Novara

  • Ospedale San Luigi Gonzaga Divisione di Ematologia

    Orbassano (TO)

  • Azienda Ospedaliera Perugia

    Perugia

  • Ospedale San Giovanbni Battista-Molinette

    Torino

  • Ospedale San Giovanni Battista -Molinette

    Torino

  • Ospedale San Bortolo

    Vicenza

Other trials in Italy

About this study

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

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

Being tested
ATO + Ascorbic acid
Keywords
myelodysplastic syndromes, arsenic trioxide, ascorbic acid
Medical subject headings
Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATO + Ascorbic acidDrug

    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.

Study groups in NCT00803530
Study groupRoleWhat they receive
1ExperimentalLoading phase (week 1): ATO 0.3 mg/Kg/die for 5 consecutive days. * Subsequent phase (from week 2 to week 16): ATO 0.25 mg/kg twice a week (day 2 and 5 of every week). * Ascorbic acid 1000 mg IV within 30 minutes after each arsenic trioxide infusion for 16 consecutive weeks.
Receives: Drug: ATO + Ascorbic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 16 mounths

Secondary outcomes (1)

  1. 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

    Measured: 16 mounths

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2008 (estimated)
  2. Study startSep 2005
  3. Primary completionJan 2007
  4. Study completionAug 2010

Why it stopped: difficulties of enrollement

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00803530
Sponsor's protocol ID
AISSM02A
Other IDs
EudracT Number 2005-001321-28
Status last verified
Jun 2011
First submitted
4 Dec 2008
Last updated
28 Jun 2011
Results posted
No
Data monitoring committee
No

Publications

  • Galimberti S, Guerrini F, Salvi F, Petrini I, Gioia D, Messa E, Palumbo GA, Cilloni D, Petrini M, Levis A. Arsenic trioxide and ascorbic acid interfere with the BCL2 family genes in patients with myelodysplastic syndromes: an ex-vivo study. J Hematol Oncol. 2012 Sep 10;5:53. doi: 10.1186/1756-8722-5-53.

    PubMed 22964015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ATO + Ascorbic acid in people with Myelodysplastic Syndromes, run by Fondazione Italiana Sindromi Mielodisplastiche-ETS at 13 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: difficulties of enrollement). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00803530, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in