ALLIXA: Study of Ixazomib in Children with Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Phase I Study of Intravenous Ixazomib in Pediatric Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma


Leukemia / Lymphoma

Diseases Treated:

Eligibility Overview:

  • Younger than 18 years old at time of enrollment
  • Diagnosis of relapsed/refractory acute lymphoblastic leukemia (ALL) or relapsed/refractory lymphoblastic lymphoma (LLy)
  1. Brief Summary

    This is a study to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of ixazomib when given intravenously with multiagent chemotherapy to children with relapsed or refractory acute lymphoblastic leukemia or lymphoblastic lymphoma.

    This is the first study to evaluate intravenous ixazomib, a proteasome inhibitor, in pediatric patients.

    Patients will participate in the study for a single 29-day cycle of ixazomib. Doses of ixazomib will be escalated according to a standard 3+3 dose escalation schema. Ixazomib will be administered in combination with multiagent reinduction therapy. Patients will be followed up to Day 60 after the first dose of study drug for a follow-up assessment.

    Primary Objective

    • To determine the MTD and/or RP2D of ixazomib administered intravenously, in combination with multiagent reinduction chemotherapy, in pediatric patients with relapsed/refractory ALL or relapsed/refractory LLy

    Eligibility Criteria

    Inclusion criteria include:

    • Younger than 18 years old at time of enrollment 
    • Diagnosis of relapsed/refractory ALL, with or without extramedullary disease, or relapsed/refractory LLy
    • Must have at least 5% blasts in the bone marrow
    • Adequate organ function
    • Failure of one or more therapeutic attempts
    • Recovered from acute toxic effects of prior treatment

    Exclusion Criteria include:

    • Has isolated extramedullary disease, including central nervous system (CNS) or testicular disease
    • Has planned administration of chemotherapy, radiation therapy or immunotherapy, other than the study drugs used for this protocol
    • Has deoxyribonucleic acid fragility syndromes
    • Is receiving cyclosporine, tacrolimus or other agents to prevent graft-vs-host disease (GVHD) after hemopoietic stem cell transplant
    • Has Philadelphia chromosome (Ph)-positive ALL or Ph-like ALL and is currently receiving tyrosine kinase inhibitor therapy

    Study Sites

    St. Jude Children’s Research Hospital, Memphis, Tennessee
    Collaborating sites in and outside the U.S.

  2. About this study

    This clinical trial is for children with acute lymphoblastic leukemia[SJ1]  (ALL) or lymphoblastic lymphoma [SJ2] (LLy) that has come back (relapsed) or did not respond to standard therapy.

    Researchers will test new treatments that combine an experimental drug with other chemotherapy drugs. This combination of drugs has never been tested in children.

    The experimental drug in this study is called ixazomib. It is considered an experimental drug because it has not been proven to work in treating pediatric leukemia and lymphoma and the U.S. Food and Drug Administration has not approved the drug.

    Ixazomib prevents proteins in the cancer cell from being broken down. This process may make cancer cells more sensitive to chemotherapy and radiation therapy.

    In this study, ixazomib will be given intravenously (through the veins), along with standard chemotherapy drugs.

    Taking part in this study may or may not benefit you. However, information learned from this study may help future children or young adults with relapsed ALL and LLy.

    Purpose of this clinical trial

    The main goal of this study is to find the best dose of ixazomib to use together with multiagent chemotherapy in children without causing severe side effects.

    Eligibility overview

    • Younger than 18 years old at time of enrollment
    • Diagnosis of relapsed/refractory ALL, with or without extramedullary disease, or relapsed/refractory LLy
  3. ALLIXA Quick View
    Sponsors Millennium Pharmaceuticals identifier NCT03888534
    Trial Start Date September 2019
    Estimated Enrollment 18 (5 at St. Jude)
    Study Type Interventional
    Study Phase Phase I
    Conditions Acute lymphoblastic leukemia, lymphoblastic lymphoma               
    Ages Younger than 18
    Principal investigator Tanja Gruber, MD, PhD
    Study Sites St. Jude Children’s Research Hospital and collaborating sites in and outside the U.S.
    For a consultation or to discuss ALLIXA St. Jude Physician/Patient Referral Office


Tanja Gruber, MD, PhD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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