Title
A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) 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

Description
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

Objective
The purpose of Induction and Consolidation phases of therapy is to kill as many of the cancer cells as possible so the disease goes into remission. The purpose of the remainder of therapy is to make sure it doesn’t come back. Treatment is divided into the following phases: Interim Maintenance I, Delayed Intensification, Interim Maintenance II, and Maintenance

Treatment Please contact study coordinator for details

Key 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 7 business days after enrollment for 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 and MUST submit eligibility studies as defined by the protocol

Must be greater than 365 days and less than 25 years of age

White blood cell count as defined by the protocol

Newly diagnosed B-ALL or MPAL (by WHO2016 criteria) with greater than25% blasts on a bone marrow (BM) aspirate; OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy; OR A complete blood count (CBC) documenting the presence of at least 1,000/μL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed; OR Patient has newly diagnosed B-LLy Murphy Stages III or IV; OR Patient has newly diagnosed B-LLy Murphy Stages I or II with steroid pretreatment as defined by the protocol

EXCLUSION

Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group)

Known Charcot-Marie-Tooth disease

With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732

B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing greater than1,000/μL circulating leukemia cells

Acute Undifferentiated Leukemia (AUL) are not eligible

Murphy Stage III/IV B-LLy patients, or Stage I/II patients with steroid pretreatment, the following additional exclusion criteria apply: T-Lymphoblastic Lymphoma, Morphologically unclassifiable lymphoma, Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma

Can not be pregnant or breastfedding

Male and Female of childbearing potentail must agree to adequate birth control as defined by the protocol

Applicable Disease Sites
Leukemia; Lymphoma

Participating Institutions
Gundersen Health System; UW Health University Hospital