A Phase I Study of Ixazomib in Pediatric Participants with Recurrent or Persistent Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

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Full Title

Open-Label Phase 1 Study to Assess the Maximum Tolerated Dose, Pharmacokinetics, and Safety of Ixazomib Administered Intravenously to Pediatric Patients Aged 0 to <18 Years With Relapsed or Refractory Acute Lymphoblastic Leukemia, With or Without Extramedullary Disease, or Relapsed or Refractory Lymphoblastic Lymphoma

Purpose

In this study, researchers want to find the best dose of the drug ixazomib that can be given safely with standard chemotherapy in children with acute lymphoblastic leukemia or lymphoblastic lymphoma that has come back or continued to grow despite prior therapy. Ixazomib may help the chemotherapy to work better.

Ixazomib is a “proteasome inhibitor,” a type of drug that blocks a protein in cancer cells from being broken down and makes cancer cells more sensitive to chemotherapy. Ixazomib is used to treat certain types of multiple myeloma in adults. It is taken orally (by mouth).

Eligibility

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

  • Patients must have recurrent or persistent acute lymphoblastic leukemia or lymphoblastic lymphoma.
  • Patients should recover from the serious side effects of prior treatments before entering the study.
  • This study is for patients under age 18.

For more information and to inquire about eligibility for this study, please contact Dr. Peter Steinherz at 212-639-7951.

Protocol

19-385

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators