deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT00460421

A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT

A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Pediatric Subjects With Acute Leukemias Undergoing Myeloablative Therapy and Allogeneic Hematopoietic Stem Cell Transplant (HSCT)

Sponsor: Swedish Orphan Biovitrum

Conditions Leukemia
Updated 9 times since 2017 Last updated: Nov 4, 2014 Started: Aug 31, 2006 Primary completion: May 31, 2011 Completion: May 31, 2011

Listed as NCT00460421, this PHASE1 trial focuses on Leukemia and remains completed. Sponsored by Swedish Orphan Biovitrum, it has been updated 9 times since 2006, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Dec 2022 · 12 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 · 19 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE1

  4. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE1

  5. Dec 2021 — Dec 2022 [monthly]

    Completed PHASE1

Show 4 earlier versions
  1. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE1

  2. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

  3. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1

  4. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1

    First recorded

Aug 2006

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Swedish Orphan Biovitrum
Data source: Swedish Orphan Biovitrum

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