Actively Recruiting
Phase II Study of Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for Adults Newly Diagnosed With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Lymphoma
Led by University of Washington · Updated on 2026-04-16
33
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
T
Takeda
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment involving dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) with or without rituximab plus ponatinib for adults newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia or lymphoma (ALL). This phase II trial aims to assess the safety, tolerability, and effectiveness of these medications in treating this type of blood cancer. The study focuses on understanding the rate of complete molecular response within approximately three months of treatment. Participants receive etoposide, doxorubicin, and vincristine intravenously over 96 hours during days 1 to 4 of each cycle, cyclophosphamide IV on day 5, and prednisone orally twice daily on days 1 to 5. Ponatinib is given orally once daily for the first 21 days of each cycle. Patients receive filgrastim or pegfilgrastim subcutaneously to support white blood cell recovery after chemotherapy. Those who test positive for CD20 also receive rituximab intravenously on day 1 or 5. Treatment cycles repeat every 21 days for up to 8 cycles unless the disease progresses or side effects become unacceptable. Throughout the study, participants undergo blood tests, bone marrow aspiration and biopsy, and computed tomography (CT) scans; positron emission tomography (PET)/CT scans may be done at enrollment. After treatment, patients are followed every three months for two years and then every six months for up to three more years to monitor their health and response. The study tracks outcomes like molecular response rates, adverse events, remission duration, survival, and treatment feasibility over several years.
CONDITIONS
Brief 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 aged 18 years and older with newly diagnosed Philadelphia chromosome positive B-cell acute lymphoblastic leukemia
- Detectable abnormal lymphoblasts in marrow or blood by flow cytometry
- Total bilirubin at or below 1.5 times the upper limit of normal unless due to inherited conditions, then up to 4 times normal
- Liver enzymes (AST/ALT) at or below 2.5 times institutional upper limit unless due to leukemia involvement, then up to 8 times normal
- Creatinine clearance greater than 30 ml/min/1.73m2
- No required blood count levels for enrollment, but adequate recovery needed before subsequent treatments
- ECOG performance status between 0 and 2, or 3 if due to leukemia
- Ability to consent and follow study procedures
- Expected survival of at least 3 months
- Females with reproductive potential must agree to use birth control during and after treatment as specified
- Males must agree to use birth control and not donate sperm during and after treatment as specified
You will not qualify if you...
- Diagnosis of Burkitt lymphoma or leukemia
- Prior systemic therapy for acute lymphoblastic leukemia except short-term treatments for symptom control
- Presence of isolated extramedullary or known parenchymal central nervous system disease
- History of acute pancreatitis within 1 year or chronic pancreatitis
- Symptomatic cardiovascular disease such as heart attack or stroke within 1 year
- Resistant high blood pressure despite three antihypertensive medications
- Venous blood clots within 6 months before enrollment
- Known allergies or intolerance to study drugs
- Other medical or psychiatric conditions preventing safe participation
- Pregnancy or nursing; specific nursing restrictions based on rituximab use and reproductive potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 8 cycles of 21 days each
Participants receive dose-adjusted chemotherapy with etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and ponatinib over repeated 21-day cycles. CD20 positive participants also receive rituximab. Supportive injections with filgrastim or pegfilgrastim are given to help recovery. Treatment cycles repeat every 21 days for up to 8 cycles unless disease progresses or toxicity occurs. Participants undergo blood sample collection, bone marrow aspiration and biopsy, and CT scans during treatment. PET/CT may be done at enrollment.
Repeated visits every 21 days for up to 8 cycles
Duration - Up to 5 years
After treatment ends, participants are followed to monitor health outcomes and detect any relapse or adverse effects. Follow-up visits occur every 3 months for 2 years, then every 6 months for up to 3 more years.
Visits every 3 months for 2 years, then every 6 months for up to 3 years
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
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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