Study on Dose-Adjusted EPOCH with or without Rituximab Plus Ponatinib for Treating Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07224100

Provider View

This clinical trial is exploring a treatment for patients newly diagnosed with Philadelphia chromosome positive acute lymphoblastic leukemia or lymphoma (Ph+ ALL). The study is testing a combination of chemotherapy drugs, with or without rituximab, plus ponatinib to see if it is safe and effective in treating this type of cancer.

Patient Parameters

Program Overview

This phase II study is testing a combination of chemotherapy drugs, known as DA-EPOCH, with or without rituximab, plus ponatinib in patients who have been newly diagnosed with Philadelphia chromosome positive acute lymphoblastic leukemia or lymphoma (Ph+ ALL). The chemotherapy drugs work by stopping cancer cells from growing and dividing, while rituximab helps the immune system target cancer cells. Ponatinib is a drug that blocks certain proteins to prevent cancer cells from growing. The study aims to determine if this combination is safe and effective for treating Ph+ ALL.

Description

In this study, patients will receive a combination of chemotherapy drugs, including etoposide, doxorubicin, and vincristine, given through an IV over four days, along with cyclophosphamide on the fifth day. They will also take prednisone by mouth for five days and ponatinib daily for 21 days in each cycle. Patients who have a specific marker (CD20 positive) will also receive rituximab. The treatment cycles repeat every 21 days for up to eight cycles, as long as the cancer does not progress and side effects are manageable. Patients will have regular blood tests, bone marrow tests, and scans to monitor their response to the treatment. After completing the treatment, patients will have follow-up visits every three months for two years, then every six months for up to three years.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia or lymphoma (Ph+ ALL).
  • Cancer must be detectable in the blood or bone marrow.
  • Liver function tests must be within specified limits, unless due to certain conditions.
  • Kidney function must be adequate.
  • No specific blood count requirements for starting treatment, but recovery is needed for subsequent cycles.
  • General health status must be good, with some exceptions for those affected by ALL.
  • Must be able to give informed consent and follow the study protocol.
  • Expected to live at least three months, regardless of ALL.
  • Women of childbearing potential must use effective birth control during and after treatment, with specific timelines based on the drugs received.
  • Men must use effective birth control and not donate sperm during and after treatment.

Exclusion Criteria

  • Diagnosis of Burkitt lymphoma/leukemia.
  • Previous systemic treatment for ALL, except for managing acute symptoms.
  • No isolated or known central nervous system disease.
  • History of pancreatitis within the past year.
  • Recent serious heart or blood vessel issues.
  • Uncontrolled high blood pressure despite treatment.
  • Recent blood clots.
  • Allergies or intolerance to study drugs.
  • Other medical or psychiatric conditions that could affect participation.
  • Cannot be pregnant or nursing, with specific guidelines for when nursing can resume based on treatment received.

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