deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01191957

Busulfan (BU) Plus Fludarabine Vs Intravenous BU Plus Cyclophosphamide as Conditioning Regimens Prior Allogeneic Hematopoetic Stem Cells Transplant (HSCT) in AML (GITMO-AMLR2)

Randomized Study Comparing i.v. Busulfan (Busilvex®) Plus Fludarabine (BuFlu) Versus Busilvex® Plus Cyclophosphamide (BuCy2) as Conditioning Regimens Prior AlloHSCT in Patients (Age >= 40 and =<65 Years) With AML in Complete Remission.

Sponsor: Gruppo Italiano Trapianto di Midollo Osseo

Updated 8 times since 2017 Last updated: Mar 9, 2023 Started: Jan 31, 2008 Primary completion: Dec 31, 2012 Completion: Oct 31, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Acute Myeloid Leukemia (AML) and is currently completed. Gruppo Italiano Trapianto di Midollo Osseo leads this study, which shows 8 recorded versions since 2008 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotCompleted~Sep 2021 – ~Apr 2023 · 19 months · monthly snapshotCompleted~Apr 2023 – ~Jul 2024 · 15 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 12 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Apr 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. Sep 2021 — Apr 2023 [monthly]

    Completed PHASE3

Show 3 earlier versions
  1. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE3

  2. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  3. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE3

    First recorded

Jan 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Gruppo Italiano Trapianto di Midollo Osseo
Data source: Gruppo Italiano Trapianto di Midollo Osseo

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