deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT00008177

Radiolabeled Monoclonal Antibody Therapy, Fludarabine Phosphate, and Low-Dose Total-Body Irradiation Followed by Donor Stem Cell Transplant and Immunosuppression Therapy in Treating Older Patients With Advanced Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

A Phase I Study Combining Escalating Doses of Radiolabeled BC8 (Anti-CD45) Antibody With Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil to Establish Mixed or Full Donor Chimerism for Elderly Patients With Advanced Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

Sponsor: Fred Hutchinson Cancer Center

Updated 10 times since 2017 Last updated: Nov 8, 2019 Started: Jul 27, 1999 Primary completion: Mar 21, 2009 Completion: Dec 15, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00008177, this PHASE1 trial focuses on Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Del(5q) and remains completed. Sponsored by Fred Hutchinson Cancer Center, it has been updated 10 times since 1999, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Dec 2017 · 10 months · monthly snapshotActive Not Recruiting~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshotActive Not Recruiting~Dec 2018 – ~Dec 2019 · 12 months · monthly snapshotActive Not Recruiting~Dec 2019 – ~Jan 2021 · 13 months · monthly snapshotCompleted~Jan 2021 – ~May 2022 · 16 months · monthly snapshotCompleted~May 2022 – ~Jul 2024 · 26 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 23 months · monthly snapshotCompleted

Change History

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

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. May 2022 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — May 2022 [monthly]

    Completed PHASE1

  5. Dec 2019 — Jan 2021 [monthly]

    Completed PHASE1

    Status: Active Not RecruitingCompleted

Show 5 earlier versions
  1. Dec 2018 — Dec 2019 [monthly]

    Active Not Recruiting PHASE1

  2. Jun 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE1

  3. Dec 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1

  4. Feb 2017 — Dec 2017 [monthly]

    Active Not Recruiting PHASE1

  5. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE1

    First recorded

Jul 1999

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
  • National Cancer Institute (NCI)
Data source: Fred Hutchinson Cancer Center

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

Study Locations