BridgeMD
New treatment option for B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
Official title 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
ClinicalTrials.gov ID: NCT06738368
What this study is testing
What is Asparaginase Erwinia chrysanthemi?
Asparaginase Erwinia chrysanthemi is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for b acute lymphoblastic leukemia, philadelphia chromosome negative.
Also referred to as Asparaginase Erwinia chrysanthemi (Recombinant)-rywn, Asparaginase Erwinia chrysanthemi, Recombinant-rywn.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Total bilirubin ≤ 2.0 x upper limit of normal (ULN) (unless attributed to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia...
You likely can't join if
- Prior systemic therapy for ALL except to control acute symptoms and/or leukocytosis (e.g., corticosteroids, cytarabine, etc.). Cytarabine 500 mg/m\^2...
- 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
See the full eligibility 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)...
- 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...
- 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...
- 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...
- Ability to give informed consent and comply with the protocol
- Anticipated survival of at least 3 months, independent of ALL
- Female people 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 people with female partners of...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.