deltatrials
Recruiting PHASE1/PHASE2 INTERVENTIONAL 3-arm NCT01371630

Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia

Phase I/II Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL)

Sponsor: M.D. Anderson Cancer Center

Conditions B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative Burkitt-Like Lymphoma With 11q Aberration High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements High Grade B-Cell Lymphoma, Not Otherwise Specified Recurrent B Acute Lymphoblastic Leukemia Recurrent Burkitt Lymphoma Refractory B Acute Lymphoblastic Leukemia Refractory Burkitt Lymphoma
Interventions Blinatumomab Cyclophosphamide Cytarabine Dexamethasone Inotuzumab Ozogamicin Laboratory Biomarker Analysis Mercaptopurine Methotrexate Prednisone Rituximab Vincristine
Updated 30 times since 2017 Last updated: Dec 16, 2025 Started: Aug 26, 2011 Primary completion: Dec 25, 2027 Completion: Dec 25, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 and B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative and is currently actively recruiting participants. M.D. Anderson Cancer Center leads this study, which shows 30 recorded versions since 2011 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~Sep 2017 · 5 months · monthly snapshot~Sep 2017 – ~Dec 2017 · 3 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshot~Nov 2018 – ~Jan 2019 · 2 months · monthly snapshot~Jan 2019 – ~Apr 2019 · 3 months · monthly snapshot~Apr 2019 – ~Jun 2019 · 2 months · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Nov 2019 · 4 months · monthly snapshot~Nov 2019 – ~Aug 2020 · 9 months · monthly snapshot~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshot~Jun 2021 – ~Mar 2022 · 9 months · monthly snapshot~Mar 2022 – ~Jul 2022 · 4 months · monthly snapshot~Jul 2022 – ~Nov 2022 · 4 months · monthly snapshot~Nov 2022 – ~Apr 2023 · 5 months · monthly snapshot~Apr 2023 – ~Oct 2023 · 6 months · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Jan 2024 · 2 months · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · 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 · 8 months · monthly snapshot

Change History

30 versions recorded

  1. Jan 2026 — Present [monthly]

    Recruiting PHASE1/PHASE2

  2. Aug 2025 — Jan 2026 [monthly]

    Recruiting PHASE1/PHASE2

  3. Feb 2025 — Aug 2025 [monthly]

    Recruiting PHASE1/PHASE2

  4. Sep 2024 — Feb 2025 [monthly]

    Recruiting PHASE1/PHASE2

  5. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

▶ Show 25 earlier versions

  1. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  2. Jan 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  3. Nov 2023 — Jan 2024 [monthly]

    Recruiting PHASE1_PHASE2

  4. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE1_PHASE2

  5. Apr 2023 — Oct 2023 [monthly]

    Recruiting PHASE1_PHASE2

  6. Nov 2022 — Apr 2023 [monthly]

    Recruiting PHASE1_PHASE2

  7. Jul 2022 — Nov 2022 [monthly]

    Recruiting PHASE1_PHASE2

  8. Mar 2022 — Jul 2022 [monthly]

    Recruiting PHASE1_PHASE2

  9. Jun 2021 — Mar 2022 [monthly]

    Recruiting PHASE1_PHASE2

  10. Apr 2021 — Jun 2021 [monthly]

    Recruiting PHASE1_PHASE2

  11. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE1_PHASE2

  12. Jan 2021 — Mar 2021 [monthly]

    Recruiting PHASE1_PHASE2

  13. Aug 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  14. Nov 2019 — Aug 2020 [monthly]

    Recruiting PHASE1_PHASE2

  15. Jul 2019 — Nov 2019 [monthly]

    Recruiting PHASE1_PHASE2

  16. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE1_PHASE2

  17. Apr 2019 — Jun 2019 [monthly]

    Recruiting PHASE1_PHASE2

  18. Jan 2019 — Apr 2019 [monthly]

    Recruiting PHASE1_PHASE2

  19. Nov 2018 — Jan 2019 [monthly]

    Recruiting PHASE1_PHASE2

  20. Jun 2018 — Nov 2018 [monthly]

    Recruiting PHASE1_PHASE2

  21. Dec 2017 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  22. Sep 2017 — Dec 2017 [monthly]

    Recruiting PHASE1_PHASE2

  23. Apr 2017 — Sep 2017 [monthly]

    Recruiting PHASE1_PHASE2

  24. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE1_PHASE2

  25. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Aug 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