Inotuzumab Ozogamicin for Newly Diagnosed High-Risk B-ALL

What is the Purpose of this Study?

This study focuses on individuals who have been diagnosed with mixed-phenotype acute leukemia (MPAL). MPAL is a cancer of the white blood cells that occurs in the bone marrow and is a rare form of leukemia. The purpose of the study is to determine the outcomes of MPAL patients with a favorable early response to receiving a treatment called High-Risk, B-Cell Acute Lymphoblastic Leukemia therapy (HR B‑ALL therapy). This treatment is a combination of chemotherapy medications; some patients may also need radiation therapy.

In the first phases of treatment (Induction and Consolidation), chemotherapy is used to try to remove all visible signs of leukemia and allow normal blood cell production to be restored (remission). The goal of the rest of therapy (Interim Maintenance I, Delayed Intensification, Interim Maintenance II and Maintenance) is to remove any remaining leukemia cells to prevent the leukemia from returning. The use of standard-of-care HR B-ALL treatment in patients with MPAL is experimental.

Part 2 of the study is post-consolidation therapy for participants who are assigned to either the High Risk Favorable (HR-Fav) B‑ALL or High Risk (HR) B-ALL risk group at the end of Part 1. Researchers aim to determine whether adding inotuzumab ozogamicin to standard-of-care chemotherapy maintains or improves outcomes in HR B-ALL patients. In HR-Fav participants, the study aims to describe outcomes when patients are treated with one phase of Interim Maintenance instead of two.

Additionally, the study enrolls patients with disseminated B-cell lymphoblastic lymphoma (B-LLy) (lymphoma found in more than one part of the body). Researchers will evaluate the outcomes of participants with disseminated B‑LLy receiving High Risk B-cell acute lymphoblastic leukemia therapy. The treatment involves chemotherapy; some patients may also need radiation therapy depending on whether the lymphoma has spread to the brain and spinal fluid, or testes for males. (B-LLy patients on this study will not receive the investigational medicine, inotuzumab ozogamicin.)


Eligibility

  • B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 days of enrollment for suspected MPAL patients. If not performed within this time frame, patients will be taken off protocol.
  • APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732.
  • Patients must be > 365 days and < 25 years of age
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Where can I participate?

Cedars-Sinai Cancer at SOCC

More about this Clinical Trial

What is the full name of this clinical trial?

AALL1732: A Phase 3 Randomized Trial of Inotuzumab Ozogamicin for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy ^

Study Details
Disease Type/Condition

Leukemia, not otherwise specified

Principal Investigator

Baca, Nicole

Co-Investigators

Fataneh Majlessipour, Leo Mascarenhas

Age Group

Children

Phase

III

IRB Number

STUDY00000654

ClinicalTrials.gov ID

NCT03959085

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Leukemia, not otherwise specified

Principal Investigator

Baca, Nicole

Age Group

Children

Phase

III

IRB Number

AALL1732

ClinicalTrials.gov ID

NCT03959085

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org