deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT00719888

Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease

Transplantation of Umbilical Cord Blood for Patients With Hematological Diseases With Cyclophosphamide/Fludarabine/Total Body Irradiation or Cyclophosphamide/Fludarabine/Thiotepa/Total Body Irradiation Myeloablative Preparative Regimen

Sponsor: Fred Hutchinson Cancer Center

Updated 26 times since 2017 Last updated: Mar 4, 2025 Started: Nov 18, 2005 Primary completion: Dec 22, 2023 Completion: Dec 19, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00719888, this PHASE2 trial focuses on Acute Biphenotypic Leukemia and Acute Lymphoblastic Leukemia and remains completed. Sponsored by Fred Hutchinson Cancer Center, it has been updated 26 times since 2005, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients receive myeloablative conditioning comprising fludarabine intravenously (IV) over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI twice daily (BID) on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0. ARM II: Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI once daily (QD) on days -2 and -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine orally (PO) (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) three times daily (TID) on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after...

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I: Patients receive myeloablative conditioning comprising fludarabine intravenously (IV) over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI twice daily (BID) on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0.

ARM II: Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI once daily (QD) on days -2 and -1. Patients then undergo single- or double-unit UCBT on day 0.

Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine orally (PO) (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) three times daily (TID) on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD.

After completion of study treatment, patients are followed up at 6 months, 1 year, and 2 years.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~Oct 2017 · 2 months · monthly snapshot~Oct 2017 – ~Apr 2018 · 6 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Jun 2019 · 4 months · monthly snapshot~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshot~Aug 2019 – ~Mar 2020 · 7 months · monthly snapshot~Mar 2020 – ~Sep 2020 · 6 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~May 2021 · 2 months · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Apr 2022 · 7 months · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Sep 2022 · 4 months · monthly snapshot~Sep 2022 – ~Feb 2023 · 5 months · monthly snapshot~Feb 2023 – ~Aug 2023 · 6 months · monthly snapshot~Aug 2023 – ~Feb 2024 · 6 months · monthly snapshot~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshot~Apr 2025 – present · 12 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

26 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Apr 2025 — Present [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  3. Sep 2024 — Apr 2025 [monthly]

    Active Not Recruiting PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2

  5. Feb 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2

Show 21 earlier versions
  1. Aug 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE2

  2. Feb 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  3. Sep 2022 — Feb 2023 [monthly]

    Recruiting PHASE2

  4. May 2022 — Sep 2022 [monthly]

    Recruiting PHASE2

  5. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE2

  6. Sep 2021 — Apr 2022 [monthly]

    Recruiting PHASE2

  7. May 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  8. Mar 2021 — May 2021 [monthly]

    Recruiting PHASE2

  9. Jan 2021 — Mar 2021 [monthly]

    Recruiting PHASE2

  10. Sep 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  11. Mar 2020 — Sep 2020 [monthly]

    Recruiting PHASE2

  12. Aug 2019 — Mar 2020 [monthly]

    Recruiting PHASE2

  13. Jun 2019 — Aug 2019 [monthly]

    Recruiting PHASE2

  14. Feb 2019 — Jun 2019 [monthly]

    Recruiting PHASE2

  15. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE2

  16. Jun 2018 — Jan 2019 [monthly]

    Recruiting PHASE2

  17. Apr 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

  18. Oct 2017 — Apr 2018 [monthly]

    Recruiting PHASE2

  19. Aug 2017 — Oct 2017 [monthly]

    Recruiting PHASE2

  20. Feb 2017 — Aug 2017 [monthly]

    Recruiting PHASE2

  21. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Nov 2005

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Fred Hutchinson Cancer Center
Data source: Fred Hutchinson Cancer Center

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