DA-EPOCH with or without Rituximab Plus Ponatinib for Newly-Diagnosed Ph+ ALL
This study is testing a treatment combination for adults newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia or lymphoma (ALL). You might be eligible if you are 18 or older and have this specific type of leukemia or lymphoma, which is identified by a special genetic change called BCR::ABL1. The treatment involves a chemotherapy regimen called DA-EPOCH (dose-adjusted etoposide, doxorubicin, vincristine, cyclophosphamide, and prednisone), along with ponatinib. Some patients will also receive rituximab. Researchers want to see how many patients achieve a complete molecular response (meaning no detectable leukemia cells) after about three months of treatment. The study aims to enroll 33 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study, but the phase is not specified. It plans to enroll 33 participants.
- What's involved
- You would receive chemotherapy and ponatinib in cycles every 21 days for up to 8 cycles. You would also have blood tests, bone marrow procedures, and CT scans throughout the study, and potentially a PET/CT scan at the start.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you would be followed every 3 months for 2 years, then every 6 months for up to 3 years.
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NCT07224100
Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of WashingtonInvestigator-initiated
~33 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:CyclophosphamideDoxorubicinEtoposideFilgrastimPegfilgrastimPonatinib
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of complete molecular response
Measured over Up to completion of 4 cycles (approximately 3 months) (cycle length = 21 days)
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- Ryan Cassaday, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Adults (age 18 years and older) with newly-diagnosed Ph+ B-ALL. Ph status will be determined by routine cytogenetics, fluorescence in situ hybridization (FISH), and/or reverse transcriptase-polymerase chain reaction (RT-PCR) for the BCR::ABL1 translocation
Marrow or blood involvement by abnormal lymphoblasts detectable by multiparameter flow cytometry (MFC)
Total bilirubin (TBili) ≤ 1.5 x upper limit of normal (ULN) (unless attributed to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point TBili must be ≤ 4 x ULN)
(Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the TBili is ≤ 5 x ULN)
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 x institutional ULN
(Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the ALT/AST are ≤ 8 x ULN)
Calculated creatinine clearance of \> 30 ml/min/1.73m\^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
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)
Ability to give informed consent and comply with the protocol
Anticipated survival of at least 3 months, independent of ALL
Female subjects of reproductive potential must agree to use an effective method of birth control from the time of signing the consent form until one of the following:
For subjects not expected to receive rituximab (i.e., CD20-negative): at least 3 weeks after the last dose of ponatinib, or
For subjects expected to receive rituximab (i.e., CD20-positive): at least 12 months after the last dose of rituximab
A subject does not have reproductive potential if they are (1) surgically sterilized, or (2) postmenopausal (i.e., a female who is \> 50 years old or who has not had menses for ≥ 1 year), or (3) not heterosexually active
Male subjects must agree to use an effective method of birth control and to not donate sperm from the time of signing the consent form until at least 3 weeks after the last dose of ponatinib
Exclusion
Burkitt lymphoma/leukemia
No prior systemic therapy for ALL except to control acute symptoms and/or hyperleukocytosis (e.g., corticosteroids, cytarabine, etc.)
No isolated extramedullary or known parenchymal central nervous system (CNS) disease
History of acute pancreatitis within 1 year of enrollment or known chronic pancreatitis
Symptomatic atherosclerotic cardiovascular disease (e.g., myocardial infarction, cerebrovascular accident, peripheral arterial disease, etc.) within 1 year of enrollment
Active resistant hypertension, defined as having an ambulatory blood pressure above goal despite use of 3 antihypertensive medications from different classes
Venous thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months of enrollment
Known hypersensitivity or intolerance to any of the agents under investigation
Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol
May not be pregnant or nursing. Pregnancy test is only required in females, unless they do not have reproductive potential. For subjects not expected to receive rituximab (i.e., CD20-negative), nursing can occur 1 week after the last dose of ponatinib. For subjects expected to receive rituximab (i.e., CD20-positive), nursing can occur 6 months after the last dose of rituximab
What this trial measures
- Rate of complete molecular responseUp to completion of 4 cycles (approximately 3 months) (cycle length = 21 days)
Will be evaluated by BCR::ABL1 reverse transcriptase polymerase chain reaction.