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Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia

StatusSuspended
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment suspended Sponsor's reason: Safety Review Eligibility criteria expanded, about 20 words · Secondary endpoints: details revised at 5 of 5 entries · Study description revised · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description revised
    • Site details revised
  2. Re-verified, no change to tracked fieldsv11
  3. Start date changed from estimate of May 1, 2026 to May 8, 2026v10
  4. Start date: Apr 1, 2026 to May 1, 2026v9
  5. Start date: Mar 1, 2026 to Apr 1, 2026v8
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Start date: Feb 1, 2026 to Mar 1, 2026 · Site details revisedv7 Show 2 more changesShow less
    • Start date: Feb 1, 2026 to Mar 1, 2026
    • Site details revised
  2. Start date: Jan 1, 2026 to Feb 1, 2026v6
  3. Re-verified, no change to tracked fieldsv5
  4. Start date: Dec 1, 2025 to Jan 1, 2026 Primary completion date: Dec 31, 2027 to Jan 31, 2028 · Completion date: Jun 30, 2028 to Jul 30, 2028v4 Show 2 more changesShow less
    • Primary completion date: Dec 31, 2027 to Jan 31, 2028
    • Completion date: Jun 30, 2028 to Jul 30, 2028
  5. Start date: Sep 1, 2025 to Dec 1, 2025v3
  6. Start date: Jun 1, 2025 to Sep 1, 2025v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase II trial tests how well etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin (DA-EPOCH) with or without rituximab plus recombinant Erwinia asparaginase (JZP458) works in treating patients with newly diagnosed Philadelphia chromosome (Ph) negative B-acute lymphoblastic leukemia (ALL) or T-ALL. Chemotherapy drugs, such as etoposide, vincristine, cyclophosphamide and doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. JZP458 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving DA-EPOCH with or without rituximab plus JZP458 may kill more cancer cells in patients with newly diagnosed Ph negative B-ALL or T-ALL.
Trial Details
NCT Number NCT06738368
Lead Sponsor University of Washington
Collaborators: Jazz Pharmaceuticals
Conditions B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, T Acute Lymphoblastic Leukemia
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov