Is participation in this Seattle clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative Clinical Trial in Seattle, WA

Q: Is NCT06738368 recruiting in Seattle, WA?

Yes, NCT06738368 is currently recruiting participants at its Seattle, WA location. This b acute lymphoblastic leukemia, philadelphia chromosome negative clinical trial is actively enrolling qualified participants.

Q: How do I join the b acute lymphoblastic leukemia, philadelphia chromosome negative clinical trial in Seattle?

To join this clinical trial in Seattle, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative Study in Seattle

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.

Sponsor: University of Washington

Who Can Participate

Inclusion Criteria

Adults (age 18 years and older) with newly-diagnosed Ph- B-ALL or T-ALL

In the opinion of the treating investigator, patients must be an unsuitable candidate for a pediatric-inspired regimen, reasons for which may include (but not be limited to) older age (e.g., ≥ 40 years), practical/logistical barriers to or toxicity concerns from administration of a pediatric-inspired regimen

Marrow or blood involvement by ALL detectable by multi-parameter flow cytometry (MFC)

Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. (Performance status of 3 will be allowed if poor performance status is thought to be directly secondary to ALL.)

Total bilirubin ≤ 2.0 x upper limit of normal (ULN) (unless attributed to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be ≤ 4.0 x ULN) (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is ≤ 5.0 x ULN and alanine aminotransferase \[ALT\]/aspartate aminotransferase \[AST\] are ≤ 8.0 x ULN.)

AST (serum glutamic oxaloacetic transaminase \[SGOT\])/ALT (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 5.0 x institutional ULN. (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is ≤ 5.0 x ULN and ALT/AST are ≤ 8.0 x ULN.)

Calculated creatinine clearance of ≥ 60 ml/min/1.73 m\^2, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible

As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment. However, adequate recovery of blood counts will be required to receive subsequent cycles

Ability to give informed consent and comply with the protocol

Anticipated survival of at least 3 months, independent of ALL

Female subjects of childbearing potential should use effective non-hormonal contraceptive methods during treatment with JZP458 and for 3 months after the last dose of study drug. Male subjects with female partners of childbearing potential must agree to use an effective method of birth control from the time of signing the consent form until at least 3 months after the last dose of study drug

Exclusion Criteria

Prior systemic therapy for ALL except to control acute symptoms and/or leukocytosis (e.g., corticosteroids, cytarabine, etc.). Cytarabine 500 mg/m\^2 per dose up to 2 doses and/or the equivalent of prednisone 50 mg/m\^2/day for up to 2 days are permitted

Burkitt lymphoma/leukemia

Isolated extramedullary or known parenchymal central nervous system (CNS) disease

Known hypersensitivity or intolerance to any of the agents under investigation

Known history of grade 3+ pancreatitis or chronic pancreatic insufficiency

Known active chronic liver disease including, but not limited to, non-alcoholic steatohepatitis, cirrhosis, or non-alcoholic fatty liver disease

Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol

Pregnant or nursing

Pregnancy test is only required in women, unless they are highly unlikely to conceive (defined as \[1\] surgically sterilized, or \[2\] postmenopausal \[i.e., a woman who is \> 50 years old or who has not had menses for ≥ 1 year\], or \[3\] not heterosexually active)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Seattle?

Yes, this clinical trial (NCT06738368) has an active research site in Seattle, WA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative Treatment Options in Seattle, WA

If you're searching for b acute lymphoblastic leukemia, philadelphia chromosome negative treatment options in Seattle, WA, this clinical trial (NCT06738368) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Seattle research site is actively enrolling participants for this clinical trial. You'll receive care from experienced b acute lymphoblastic leukemia, philadelphia chromosome negative specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all b acute lymphoblastic leukemia, philadelphia chromosome negative clinical trials near you to find additional studies recruiting in your area.

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative Clinical Trial in Seattle, WA

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