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.
OUTLINE: Patients receive etoposide intravenously (IV), doxorubicin IV, and vincristine IV over 96 hours on days 1-4, cyclophosphamide IV over 1 hour on day 5, and prednisone orally (PO) twice daily (BID) on days 1-5 and ponatinib PO once daily (QD) on days 1-21 of each cycle. Patients receive filgrastim subcutaneously (SC) on day 6, 7, or 8 and continue until absolute neutrophil count (ANC) \> 2000/µL past nadir or pegfilgrastim SC on day 6, 7, or 8 of each cycle. Patients who are CD20 positive also receive rituximab IV on day 1 or 5 of each cycle. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration and biopsy and computed tomography (CT) throughout the study. Additionally, patients may undergo positron emission tomography (PET)/CT at enrollment. After completion of study treatment, patients are followed every 3 months for 2 years, then every 6 months for up to 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Given IV
Given IV
Given IV
Given SC
Given SC
Given PO
Given PO
Given IV
Given IV
Undergo blood sample collection
Undergo bone marrow aspiration and biopsy
Undergo bone marrow aspiration and biopsy
Undergo CT and PET/CT
Undergo PET/CT
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Rate of complete molecular response
Will be evaluated by BCR::ABL1 reverse transcriptase polymerase chain reaction.
Time frame: Up to completion of 4 cycles (approximately 3 months) (cycle length = 21 days)
Incidence of non-hematologic toxicities greater than or equal to grade 3
Will be graded in severity according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be reported as ratios/percentages. Will exclude asymptomatic grade 3 laboratory abnormalities.
Time frame: Up to 30 days after last dose of study treatment
Incidence of serious adverse events
Will be graded in severity using NCI CTCAE v 5.0. Will be reported as ratios/percentages.
Time frame: Up to 30 days after last dose of study treatment
Frequency of patients unable to complete one full cycle of etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin +/- rituximab + ponatinib (Feasibility)
Will be assessed descriptively, using means and associated confidence intervals for continuous measures, simple ratios and Clopper-Pearson confidence intervals for binary measures, and either Kaplan-Meier or cumulative incidence estimates for time-to-event outcomes (depending on whether competing risks are present).
Time frame: Up to 5 years after last dose of study treatment
Event-free survival
Will be assessed descriptively, using means and associated confidence intervals for continuous measures, simple ratios and Clopper-Pearson confidence intervals for binary measures, and either Kaplan-Meier or cumulative incidence estimates for time-to-event outcomes (depending on whether competing risks are present). Kaplan-Meier curves will be used to depict survival.
Time frame: Up to 5 years after last dose of study treatment
Relapse-free survival
Will be assessed descriptively, using means and associated confidence intervals for continuous measures, simple ratios and Clopper-Pearson confidence intervals for binary measures, and either Kaplan-Meier or cumulative incidence estimates for time-to-event outcomes (depending on whether competing risks are present). Kaplan-Meier curves will be used to depict survival.
Time frame: Up to 5 years after last dose of study treatment
Duration of remission
Will be assessed descriptively, using means and associated confidence intervals for continuous measures, simple ratios and Clopper-Pearson confidence intervals for binary measures, and either Kaplan-Meier or cumulative incidence estimates for time-to-event outcomes (depending on whether competing risks are present). Kaplan-Meier curves will be used to depict survival.
Time frame: Up to 5 years after last dose of study treatment
Overall survival
Will be assessed descriptively, using means and associated confidence intervals for continuous measures, simple ratios and Clopper-Pearson confidence intervals for binary measures, and either Kaplan-Meier or cumulative incidence estimates for time-to-event outcomes (depending on whether competing risks are present). Kaplan-Meier curves will be used to depict survival.
Time frame: Up to 5 years after last dose of study treatment
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