Actively Recruiting
Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma
Led by University of Washington · Updated on 2026-04-16
33
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
T
Takeda
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests the effect of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) with or without rituximab plus ponatinib in treating patients newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia or lymphoma (ALL). Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill cancer cells. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is a drug that is used to treat many types of cancer and is being studied in the treatment of other types of cancer. Doxorubicin comes from the bacterium Streptomyces peucetius. It damages DNA and may kill cancer cells. It is a type of anthracycline antitumor antibiotic. DA-EPOCH involves a longer exposure time to doxorubicin, vincristine and etoposide compared to a higher concentration over a shorter time which may provide better tumor response. 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. Ponatinib blocks BCR::ABL1 and other proteins, which may help keep cancer cells from growing and may kill them. It may also prevent the growth of new blood vessels that tumors need to grow. Ponatinib is a type of tyrosine kinase inhibitor and a type of antiangiogenesis agent. Giving DA-EPOCH with or without rituximab plus ponatinib may be safe, tolerable, and/or effective in treating patients with newly diagnosed Ph+ ALL.
CONDITIONS
Official Title
Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age 18 years and older with newly diagnosed Philadelphia chromosome positive B-acute lymphoblastic leukemia
- Marrow or blood involvement by abnormal lymphoblasts detected by flow cytometry
- Total bilirubin less than or equal to 1.5 times upper normal limit unless due to inherited causes, then up to 4 times normal
- Patients with liver involvement by leukemia may have bilirubin up to 5 times normal
- AST/ALT less than or equal to 2.5 times institutional upper limit unless due to leukemia liver involvement, then up to 8 times normal
- Creatinine clearance greater than 30 ml/min/1.73m2
- No blood count requirements for first cycle; adequate blood count recovery needed for later cycles
- ECOG performance status 0 to 2 (3 permitted if due to leukemia)
- Ability to give informed consent and follow protocol
- Expected survival of at least 3 months
- Female participants of reproductive potential must agree to use effective birth control during and after treatment as specified
- Male participants must agree to use effective birth control and not donate sperm during and after treatment as specified
You will not qualify if you...
- Diagnosis of Burkitt lymphoma/leukemia
- Prior systemic therapy for acute lymphoblastic leukemia except for symptom control or hyperleukocytosis
- Isolated extramedullary or known central nervous system disease
- History of acute pancreatitis within 1 year or known chronic pancreatitis
- Symptomatic atherosclerotic cardiovascular disease within 1 year
- Resistant high blood pressure despite three different medications
- Venous thromboembolic event within 6 months
- Known allergy or intolerance to study medications
- Other medical or psychiatric conditions that would make participation unsafe
- Pregnant or nursing women (pregnancy test required for females with reproductive potential)
- Nursing restrictions based on whether rituximab is received
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
R
Ryan Cassaday, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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