Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia

StatusRecruiting
PhasePhase 2
Started

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Record History

The 50 most recent of 355 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Trial sites expanded: 280 → 285 locations
  2. Minor Site details revised at 4 of 281 sites
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  4. Minor Re-verified, no change to tracked fields
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  1. Minor Site contacts updated at 2 of 280 sites
  2. Minor Site details revised at 2 of 280 sites
  3. Minor Eligibility criteria shortened, about 7 words Show 4 more changesShow less
    • Secondary endpoints: details revised at 4 of 7 entries
    • Study description revised
    • Site details revised at 26 of 280 sites
    • Publications: details revised at 3 of 3 entries
  1. Minor Trial sites expanded: 277 → 280 locations
    • Site details revised at 1 of 280 sites
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  2. Minor Site details revised at 3 of 280 sitesv346
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  28. Minor Site details revised at 1 of 271 sitesv316
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  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II trial studies how well inotuzumab ozogamicin and blinatumomab with or without ponatinib work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back after a period of improvement (recurrent), or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug, called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving inotuzumab ozogamicin and blinatumomab with or without ponatinib may be effective in treating patients with newly diagnosed, recurrent or refractory CD22 positive B-lineage acute lymphoblastic leukemia.
Trial Details
NCT Number NCT03739814
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, Recurrent B Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia
Related terms Burkitt Lymphoma
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov