deltatrials
Recruiting PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT04315324

Study to Test OBI-3424 in Patients With T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LBL)

A Phase I/II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL)

Sponsor: National Cancer Institute (NCI)

Conditions Recurrent T Acute Lymphoblastic Leukemia Refractory T Acute Lymphoblastic Leukemia Refractory T Lymphoblastic Lymphoma T Lymphoblastic Lymphoma
Interventions AKR1C3-activated Prodrug AST-3424 Biopsy Procedure Biospecimen Collection Bone Marrow Aspiration Computed Tomography
Updated 21 times since 2020 Last updated: Aug 11, 2025 Started: Feb 8, 2021 Primary completion: Aug 1, 2026 Completion: Aug 1, 2028
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on Recurrent T Acute Lymphoblastic Leukemia and Refractory T Acute Lymphoblastic Leukemia, this trial is actively recruiting participants. The trial is conducted by National Cancer Institute (NCI) and has accumulated 21 data snapshots since 2021. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Apr 2020 – ~Sep 2020 · 5 months · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Dec 2020 · 2 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Dec 2022 · 12 months · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~May 2023 · 3 months · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Sep 2023 · 3 months · monthly snapshot~Sep 2023 – ~Mar 2024 · 6 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Sep 2025 · 9 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

21 versions recorded

  1. Sep 2025 — Present [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE2 → PHASE1/PHASE2

  2. Dec 2024 — Sep 2025 [monthly]

    Recruiting PHASE2

  3. Sep 2024 — Dec 2024 [monthly]

    Recruiting PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

  5. Mar 2024 — Jul 2024 [monthly]

    Recruiting PHASE2

    Status: Active Not Recruiting → Recruiting

▶ Show 16 earlier versions

  1. Sep 2023 — Mar 2024 [monthly]

    Active Not Recruiting PHASE2

  2. Jun 2023 — Sep 2023 [monthly]

    Active Not Recruiting PHASE2

  3. May 2023 — Jun 2023 [monthly]

    Active Not Recruiting PHASE2

  4. Feb 2023 — May 2023 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  5. Dec 2022 — Feb 2023 [monthly]

    Recruiting PHASE2

  6. Dec 2021 — Dec 2022 [monthly]

    Recruiting PHASE2

  7. Sep 2021 — Dec 2021 [monthly]

    Recruiting PHASE2

  8. May 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  9. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE2

  10. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE2

  11. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE2

  12. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE2

  13. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  14. Oct 2020 — Dec 2020 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  15. Sep 2020 — Oct 2020 [monthly]

    Not Yet Recruiting PHASE2

  16. Apr 2020 — Sep 2020 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
  • SWOG Cancer Research Network
Data source: SWOG Cancer Research Network

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

Study Locations

Albuquerque, United States , Ames, United States , Arroyo Grande, United States , Atlanta, United States , Augusta, United States , Aurora, United States , Austin, United States , Baltimore, United States , Baton Rouge, United States , Battle Creek, United States and 86 more locations