deltatrials
Completed PHASE3 INTERVENTIONAL 4-arm NCT00121303

Cytarabine and Daunorubicin With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

Randomised Induction and Post Induction Therapy in Older Patients (≥61 Years of Age) With Acute Myeloid Leukemia (AML) and Refractory Anemia With Excess Blasts (RAEB, RAEB-t)

Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland

Conditions Leukemia Myelodysplastic Syndromes
Interventions cytarabine daunorubicin hydrochloride gemtuzumab ozogamicin
Updated 5 times since 2017 Last updated: Sep 19, 2016 Started: Jan 31, 2005 Primary completion: Jan 31, 2009 Completion: Jun 30, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Leukemia and Myelodysplastic Syndromes, this trial is completed. The trial is conducted by Stichting Hemato-Oncologie voor Volwassenen Nederland and has accumulated 5 data snapshots since 2005. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

5 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  5. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE3

    First recorded

Jan 2005

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Stichting Hemato-Oncologie voor Volwassenen Nederland
Data source: Stichting Hemato-Oncologie voor Volwassenen Nederland

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

Study Locations