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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06738368
Phase
PHASE2
Status
Recruiting
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Conditions

  • B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
  • T Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Asparaginase Erwinia chrysanthemi — DRUG
    Given IM
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Collection — PROCEDURE
    Undergo bone marrow sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Cyclophosphamide — DRUG
    Given IV
  • Doxorubicin — DRUG
    Given CIV
  • Etoposide — DRUG
    Given CIV
  • Filgrastim — BIOLOGICAL
    Given SC
  • Pegfilgrastim — BIOLOGICAL
    Given SC
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Vincristine — DRUG
    Given CIV

Study Details

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.

Key Dates

Start date
May 8, 2026
Status verified
Dec 2025
Primary completion
Jan 31, 2028
Completion
Jul 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (DA-EPOCH, rituximab, JZP458)
    Patients receive etoposide IV, doxorubicin IV and vincristine IV over 96 hours on days 1-4, cyclophosphamide IV over 1 hour on day 5, prednisone PO BID on days 1-5 of each cycle. In addition, CD20 positive patients receive rituximab IV on day 1 or 5 of each cycle. Patients also receive JZP458 IM every 2-3 days on days 7-21 for up to 7 doses. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 6, 7, or 8, patients also receive pegfilgrastim SC once or filgrastim SC QD until ANC \> 2000/uL past nadir. Patients also undergo blood sample collection and bone marrow collection throughout the study. Additionally, patients with extramedullary disease may undergo CT or PET/CT throughout the study.

Primary Outcome Measure

Measurable residual disease (MRD) negativity [ Time Frame: After 4 cycles of treatment (cycle length = 21 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Kim Quach
[email protected]
206-606-8311
Ryan D. Cassaday, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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