Study on Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus JZP458 for Treating Newly Diagnosed Ph Negative B or T Acute Lymphoblastic Leukemia

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06738368

Provider View

This clinical trial is testing a combination of chemotherapy drugs, with or without rituximab and JZP458, to see how well they work in treating adults with newly diagnosed Ph negative B-acute lymphoblastic leukemia (B-ALL) or T-acute lymphoblastic leukemia (T-ALL).

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well a combination of chemotherapy drugs, including etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (known as DA-EPOCH), works in treating newly diagnosed Ph negative B-ALL or T-ALL. The study will also test if adding rituximab and JZP458 to this combination can help kill more cancer cells. Chemotherapy drugs work by stopping cancer cells from growing and spreading. Rituximab is a type of antibody that helps the immune system target cancer cells, and JZP458 may block enzymes needed for cancer cell growth.

Description

In this study, patients will receive a combination of chemotherapy drugs: etoposide, doxorubicin, and vincristine through an IV over 96 hours on days 1-4, cyclophosphamide through an IV for 1 hour on day 5, and prednisone taken by mouth twice daily on days 1-5 of each cycle. Patients with CD20 positive cancer cells will also receive rituximab through an IV on day 1 or 5 of each cycle. Additionally, patients will receive JZP458 as an injection into the muscle every 2-3 days from days 7-21, for up to 7 doses. The treatment cycles repeat every 21 days for up to 8 cycles, unless the disease progresses or side effects become too severe. Starting on day 6, 7, or 8, patients will also receive a medication to help boost white blood cell counts until they reach a safe level. Throughout the study, patients will have blood and bone marrow samples taken, and those with disease outside the bone marrow may have CT or PET/CT scans. After completing the study treatment, patients will have follow-up visits every 3 months for 2 years, then every 6 months for up to 3 years.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with newly diagnosed Ph negative B-ALL or T-ALL.
  • Patients who are not suitable for a pediatric-inspired treatment plan, possibly due to age (e.g., 40 years or older) or other concerns.
  • Cancer detected in bone marrow or blood through specific testing.
  • General health status allowing for normal activity or some restrictions.
  • Acceptable liver function as shown by specific blood tests.
  • Adequate kidney function.
  • Ability to give informed consent and follow the study protocol.
  • Expected to live at least 3 months, regardless of leukemia.
  • Women of childbearing potential must use effective non-hormonal birth control during treatment and for 3 months after the last dose. Men with partners of childbearing potential must also use effective birth control during and for 3 months after treatment.

Exclusion Criteria

  • Previous treatment for ALL, except for managing acute symptoms.
  • Diagnosis of Burkitt lymphoma/leukemia.
  • Cancer only outside the bone marrow or in the brain.
  • Allergies or intolerance to any study drugs.
  • History of severe pancreatitis or chronic pancreatic issues.
  • Active chronic liver disease.
  • Other medical or psychiatric conditions that may prevent safe participation.
  • Pregnant or breastfeeding women. Women must take a pregnancy test unless they are unlikely to conceive (e.g., surgically sterilized, postmenopausal, or not sexually active).

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