deltatrials
Recruiting PHASE2 INTERVENTIONAL 1-arm NCT01409161

Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)

Sponsor: M.D. Anderson Cancer Center

Conditions Acute Promyelocytic Leukemia With PML-RARA
Interventions Arsenic Trioxide Gemtuzumab Ozogamicin Laboratory Biomarker Analysis Tretinoin
Updated 25 times since 2017 Last updated: Dec 11, 2025 Started: Oct 5, 2011 Primary completion: Dec 18, 2027 Completion: Dec 18, 2027
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 Acute Promyelocytic Leukemia With PML-RARA, this trial is actively recruiting participants. The trial is conducted by M.D. Anderson Cancer Center and has accumulated 25 data snapshots since 2011. 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 – ~Sep 2017 · 7 months · monthly snapshot~Sep 2017 – ~Jun 2018 · 9 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Sep 2018 · 2 months · monthly snapshot~Sep 2018 – ~Dec 2018 · 3 months · monthly snapshot~Dec 2018 – ~Jun 2019 · 6 months · monthly snapshot~Jun 2019 – ~Mar 2020 · 9 months · monthly snapshot~Mar 2020 – ~Jul 2020 · 4 months · monthly snapshot~Jul 2020 – ~Sep 2020 · 2 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Jun 2022 · 13 months · monthly snapshot~Jun 2022 – ~Sep 2022 · 3 months · monthly snapshot~Sep 2022 – ~Oct 2022 · 30 days · monthly snapshot~Oct 2022 – ~May 2023 · 7 months · monthly snapshot~May 2023 – ~Nov 2023 · 6 months · monthly snapshot~Nov 2023 – ~May 2024 · 6 months · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshot~Feb 2025 – ~Aug 2025 · 6 months · monthly snapshot~Aug 2025 – ~Jan 2026 · 5 months · monthly snapshot~Jan 2026 – present · 6 months · monthly snapshot

Change History

25 versions recorded

  1. Jan 2026 — Present [monthly]

    Recruiting PHASE2

  2. Aug 2025 — Jan 2026 [monthly]

    Recruiting PHASE2

  3. Feb 2025 — Aug 2025 [monthly]

    Recruiting PHASE2

  4. Sep 2024 — Feb 2025 [monthly]

    Recruiting PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

▶ Show 20 earlier versions

  1. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE2

  2. May 2024 — Jun 2024 [monthly]

    Recruiting PHASE2

  3. Nov 2023 — May 2024 [monthly]

    Recruiting PHASE2

  4. May 2023 — Nov 2023 [monthly]

    Recruiting PHASE2

  5. Oct 2022 — May 2023 [monthly]

    Recruiting PHASE2

  6. Sep 2022 — Oct 2022 [monthly]

    Recruiting PHASE2

  7. Jun 2022 — Sep 2022 [monthly]

    Recruiting PHASE2

  8. May 2021 — Jun 2022 [monthly]

    Recruiting PHASE2

  9. Jan 2021 — May 2021 [monthly]

    Recruiting PHASE2

  10. Sep 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  11. Jul 2020 — Sep 2020 [monthly]

    Recruiting PHASE2

  12. Mar 2020 — Jul 2020 [monthly]

    Recruiting PHASE2

  13. Jun 2019 — Mar 2020 [monthly]

    Recruiting PHASE2

  14. Dec 2018 — Jun 2019 [monthly]

    Recruiting PHASE2

  15. Sep 2018 — Dec 2018 [monthly]

    Recruiting PHASE2

  16. Jul 2018 — Sep 2018 [monthly]

    Recruiting PHASE2

  17. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE2

  18. Sep 2017 — Jun 2018 [monthly]

    Recruiting PHASE2

  19. Feb 2017 — Sep 2017 [monthly]

    Recruiting PHASE2

  20. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Oct 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Data source: M.D. Anderson Cancer Center

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

Study Locations