deltatrials
Completed PHASE2 INTERVENTIONAL 6-arm NCT00397813

Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders

Low-Dose TBI Dose Escalation to Decrease Risks of Progression and Graft Rejection After Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning as Treatment for Untreated Myelodysplastic Syndrome or Myeloproliferative Disorders - A Multi-Center Trial

Sponsor: Fred Hutchinson Cancer Center

Conditions Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Chronic Myelomonocytic Leukemia Essential Thrombocythemia Myeloproliferative Neoplasm Paroxysmal Nocturnal Hemoglobinuria Polycythemia Vera Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase Primary Myelofibrosis Refractory Anemia Refractory Anemia With Excess Blasts Refractory Anemia With Ring Sideroblasts Refractory Cytopenia With Multilineage Dysplasia Refractory Cytopenia With Multilineage Dysplasia and Ring Sideroblasts de Novo Myelodysplastic Syndrome
Interventions Cyclosporine Fludarabine Phosphate Laboratory Biomarker Analysis Mycophenolate Mofetil Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Peripheral Blood Stem Cell Transplantation Total-Body Irradiation
Updated 15 times since 2017 Last updated: Jan 15, 2020 Started: Jan 31, 2006 Primary completion: Sep 30, 2017 Completion: Mar 31, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative and Chronic Myelomonocytic Leukemia, this trial is completed. The trial is conducted by Fred Hutchinson Cancer Center and has accumulated 15 data snapshots since 2006. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~Oct 2017 · 7 months · monthly snapshot~Oct 2017 – ~Nov 2017 · 31 days · monthly snapshot~Nov 2017 – ~Jun 2018 · 7 months · monthly snapshot~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshot~Nov 2018 – ~Jun 2019 · 7 months · monthly snapshot~Jun 2019 – ~Feb 2020 · 8 months · monthly snapshot~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshot~Jan 2021 – ~May 2022 · 16 months · monthly snapshot~May 2022 – ~Dec 2022 · 7 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

15 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE2

  4. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE2

  5. May 2022 — Dec 2022 [monthly]

    Completed PHASE2

▶ Show 10 earlier versions

  1. Jan 2021 — May 2022 [monthly]

    Completed PHASE2

  2. Feb 2020 — Jan 2021 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  3. Jun 2019 — Feb 2020 [monthly]

    Active Not Recruiting PHASE2

  4. Nov 2018 — Jun 2019 [monthly]

    Active Not Recruiting PHASE2

  5. Jun 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE2

  6. Nov 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

  7. Oct 2017 — Nov 2017 [monthly]

    Active Not Recruiting PHASE2

  8. Mar 2017 — Oct 2017 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  9. Feb 2017 — Mar 2017 [monthly]

    Recruiting PHASE2

  10. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Jan 2006

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)
  • National Heart, Lung, and Blood Institute (NHLBI)
Data source: Fred Hutchinson Cancer Center

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

Study Locations