deltatrials
Completed PHASE2 INTERVENTIONAL NCT00439673

PhII 5-Azacytidine Plus Valproic Acid and Eventually Atra in Intermediate II and High Risk MDS

A Open Label, Phase II, Non Randomized, Clinical Trial of Chemotherapy Treatment With 5-Azacytidine Plus Valproic Acid and Eventually Atra for Patients Diagnosed With Intermediate II and High Risk Myelodysplastic Syndrome (MDS). EudraCT Number 2005-004811-31. GIMEMA Protocol MDS0205

Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Conditions Myelodysplastic Syndromes
Interventions 5-Azacytidine ATRA Valproic Acid
Updated 8 times since 2017 Last updated: Aug 4, 2018 Started: May 31, 2007 Primary completion: Jul 31, 2010 Completion: Jul 31, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00439673, this PHASE2 trial focuses on Myelodysplastic Syndromes and remains completed. Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto, it has been updated 8 times since 2007, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshotCompleted~Sep 2018 – ~Jan 2021 · 28 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 21 months · monthly snapshotCompleted

Change History

8 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE2

  4. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE2

  5. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE2

▶ Show 3 earlier versions

  1. Sep 2018 — Jan 2021 [monthly]

    Completed PHASE2

  2. Jun 2018 — Sep 2018 [monthly]

    Completed PHASE2

  3. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE2

    First recorded

May 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Gruppo Italiano Malattie EMatologiche dell'Adulto
Data source: Gruppo Italiano Malattie EMatologiche dell'Adulto

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations