deltatrials
Recruiting PHASE1 INTERVENTIONAL 2-arm NCT04375631

CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia

CLAG-M or FLAG-Ida Chemotherapy Followed Immediately by Related/Unrelated Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1 Study

Sponsor: Fred Hutchinson Cancer Center

Conditions Recurrent Acute Myeloid Leukemia Recurrent Chronic Myelomonocytic Leukemia Recurrent Myelodysplastic Syndrome Refractory Acute Leukemia of Ambiguous Lineage Refractory Acute Myeloid Leukemia Refractory Acute Undifferentiated Leukemia Refractory Chronic Myelomonocytic Leukemia Refractory Mixed Phenotype Acute Leukemia Refractory Myelodysplastic Syndrome
Interventions Biospecimen Collection Bone Marrow Aspiration Bone Marrow Biopsy Cladribine Cyclophosphamide Cyclosporine Cytarabine Echocardiography Test Filgrastim Fludarabine Hematopoietic Cell Transplantation Idarubicin Mitoxantrone Multigated Acquisition Scan Mycophenolate Mofetil Mycophenolate Sodium Total-Body Irradiation X-Ray Imaging
Updated 26 times since 2020 Last updated: Mar 3, 2026 Started: Dec 3, 2020 Primary completion: Feb 28, 2027 Completion: Mar 17, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04375631, this PHASE1 trial focuses on Recurrent Acute Myeloid Leukemia and Recurrent Chronic Myelomonocytic Leukemia and remains actively recruiting participants. Sponsored by Fred Hutchinson Cancer Center, it has been updated 26 times since 2020, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

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

Change History

26 versions recorded

  1. Mar 2026 — Present [monthly]

    Recruiting PHASE1

  2. Sep 2025 — Mar 2026 [monthly]

    Recruiting PHASE1

  3. Mar 2025 — Sep 2025 [monthly]

    Recruiting PHASE1

  4. Dec 2024 — Mar 2025 [monthly]

    Recruiting PHASE1

  5. Sep 2024 — Dec 2024 [monthly]

    Recruiting PHASE1

▶ Show 21 earlier versions

  1. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1

  2. Feb 2024 — Jul 2024 [monthly]

    Recruiting PHASE1

  3. Aug 2023 — Feb 2024 [monthly]

    Recruiting PHASE1

  4. Jun 2023 — Aug 2023 [monthly]

    Recruiting PHASE1

  5. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE1

  6. Nov 2022 — May 2023 [monthly]

    Recruiting PHASE1

  7. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE1

  8. May 2022 — Sep 2022 [monthly]

    Recruiting PHASE1

  9. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE1

  10. Jan 2022 — Apr 2022 [monthly]

    Recruiting PHASE1

  11. Sep 2021 — Jan 2022 [monthly]

    Recruiting PHASE1

  12. Apr 2021 — Sep 2021 [monthly]

    Recruiting PHASE1

  13. Feb 2021 — Apr 2021 [monthly]

    Recruiting PHASE1

  14. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1

  15. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  16. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE1

  17. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  18. Sep 2020 — Oct 2020 [monthly]

    Not Yet Recruiting PHASE1

  19. Aug 2020 — Sep 2020 [monthly]

    Not Yet Recruiting PHASE1

  20. Jul 2020 — Aug 2020 [monthly]

    Not Yet Recruiting PHASE1

  21. Jun 2020 — Jul 2020 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

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