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Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Suspended to Recruitingv10 Show 4 more changesShow less
    • Primary and study completion dates: Mar 1, 2027 to Mar 1, 2028
    • Interventions: Allogenic Stem Cell Transplantation (Procedure), Dasatinib (Drug), Dexamethasone (Drug), Inotuzumab ozogamicin (Drug), Methotrexate (Drug)… to Dasatinib (Drug), Dexamethasone (Drug), Inotuzumab ozogamicin (Drug), Methotrexate (Drug), Ponatinib (Drug), Prednisone (Drug), Purinethol…
    • Site details revised
    • Study arms: 3 to 5
  2. Trial status: Recruiting to Suspended Sponsor's reason: Enrollment goal met; pending amendment to expand study
    • Site details revised
    v9
  3. Primary and study completion dates: Mar 1, 2025 to Mar 1, 2027v8
  4. Re-verified, no change to tracked fieldsv7
  5. Primary completion date: Jun 30, 2024 to Mar 1, 2025
    • Study completion date: May 1, 2026 to Mar 1, 2025
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Jun 30, 2023 to Jun 30, 2024v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2021 to Mar 2, 2021
    • Site details revised
    v3
  4. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This research study will add an anti-cancer drug (called inotuzumab ozogamicin also known as "InO") to treatment for participants with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Doctors leading this study hope to learn if adding InO to standard induction treatment for Ph+ ALL will lead to quicker, complete molecular remission (where the disease is not detectable even with very sensitive testing techniques). The purpose of this research is to gather information regarding the effectiveness of InO in newly-diagnosed Ph+ ALL patients that have not yet received treatment.
Trial Details
NCT Number NCT04747912
Lead Sponsor University of Chicago
Conditions
(from sponsor)		 Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, ph+ Acute Lymphoblastic Leukemia
Related terms Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov