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NCT06738368 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative and T Acute Lymphoblastic Leukemia, sponsored by University of Washington.

Recruiting
Registry status
Phase 2
Development phase
30
Enrollment target
1
Study location

NCT06738368: Recruiting Phase 2 study of B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative and T Acute Lymphoblastic Leukemia, sponsored by University of Washington.

NCT06738368 is a Phase 2 study of B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative and T Acute Lymphoblastic Leukemia that is actively recruiting participants, run by University of Washington. The registered enrollment target is 30 participants, below the 155-participant average among 6 other B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06738368, a Phase 2 study of B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative and T Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by University of Washington.

RECRUITING
Registry status
Phase 2
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

Will be measured by multi-parameter flow cytometry (MFC). Will be assessed according to the National Comprehensive Cancer Network response criteria.

Conditions Studied

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

Interventions

  • DRUG Cyclophosphamide
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Asparaginase Erwinia chrysanthemi
  • PROCEDURE Bone Marrow Collection

Study Locations (1)

Washington

  • Fred Hutch/University of Washington Cancer Consortium - Seattle

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2026-04-01
Est. Completion 2028-07-30
Phase Phase 2
University of Washington

1,048 total trials

What NCT06738368 shows while recruiting

NCT06738368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 155-participant average among 6 other B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative trials with a reported enrollment target (81% lower).

The record links to 2 conditions, with B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT06738368 reports a single indexed study location in Washington.

Frequently Asked Questions

What is clinical trial NCT06738368 about?

NCT06738368 is a clinical study titled "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". 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 leuk...

What is the current status of trial NCT06738368?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2026-04-01. Estimated completion is 2028-07-30.

What conditions does trial NCT06738368 study?

This clinical trial studies the following conditions: B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, T Acute Lymphoblastic Leukemia.

What interventions are being tested in trial NCT06738368?

The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Asparaginase Erwinia chrysanthemi (DRUG), Bone Marrow Collection (PROCEDURE).

Who is sponsoring clinical trial NCT06738368?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06738368 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06738368

Source: ClinicalTrials.gov NCT06738368, the US trial registry maintained by the National Library of Medicine. NCT06738368 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.