A Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Study of investigational medication versus another treatment for a type of blood and bone marrow cancer

Recruiting
18 years - 100 years
All
1 Location

Brief description of study.

The primary objective of the study is to compare the efficacy of ponatinib versus imatinib, administered as first-line therapy in combination with reduced-intensity chemotherapy, in patients with newly diagnosed Ph+ ALL, as measured by the MRD-negative CR rate at the end of induction

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
  • Age: 18 years - 100 years
  • Gender: All

In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2017 national comprehensive cancer network (NCCN) guidelines.
  • Cannot have any active serious infection requiring antibiotics within 14 days before the first dose of study drug.

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: TX10562

The purpose of this study is to investigate the effectiveness of an investigational medication compared to another treatment when used as the first therapy along with reduced-intensity chemotherapy in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Ph+ ALL is a type of cancer that affects the blood and bone marrow and is characterized by the presence of an abnormal chromosome called the Philadelphia chromosome.

Participants in this study will receive either the investigational medication or the other treatment, both combined with chemotherapy. The study will measure how well each treatment works by looking at the number of patients who achieve a complete response that is negative for minimal residual disease (MRD) after the initial treatment phase. MRD-negative means no signs of cancer cells are found in the bone marrow.

  • Who can participate: Participants must have been newly diagnosed with Philadelphia chromosome-positive or BCR-ABL1-positive acute lymphoblastic leukemia and must not have active serious infections requiring antibiotics within 14 days before starting the study medication.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or another treatment, both combined with chemotherapy. A placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine, may be used in the study.

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