A Phase III Study of Imatinib plus Chemotherapy According to Disease Risk in Young Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

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Full Title

International Phase 3 Trial in Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL) Testing Imatinib in Combination with Two Different Cytotoxic Chemotherapy Backbones (AALL1631) (CIRB)

Purpose

Acute lymphoblastic leukemia (ALL) with a certain genetic mutation called the Philadelphia chromosome are often treated with an oral drug called imatinib as well as chemotherapy. The chemotherapy is strong and causes side effects, but not all patients may need that level of intensity. In this study, researchers are using a test to look for minimal residual disease (MRD), a measure of how many leukemia cells remain in the body after initial (induction) treatment for ALL, and then basing the next phase of therapy for each patient based on their MRD status.

Children, adolescents, and young adults with low-risk ALL (those with low MRD) will be randomly assigned to the standard intensive chemotherapy or to a less intensive chemotherapy regimen, and the two groups will be compared. Those with high-risk ALL (high MRD) will have the standard intensive chemotherapy followed by a stem cell transplant.

It is hoped that this approach can spare some young patients from more intensive therapy and its side effects without compromising the effectiveness of treatment.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have Philadelphia chromosome-positive ALL and have started induction therapy, with no more than 14 days of chemotherapy and imatinib before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients who are older than 1 year and no older than age 21.

For more information and to inquire about eligibility for this study, please contact Dr. Kavitha Ramaswamy at 212-639-8451.

Protocol

19-487

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators