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Clinical Trials in Canada / NCT03959085
Recruiting Phase 3

Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy

NCT03959085 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2019-10-31
Last updated
2026-08-25

Condition(s) studied

B Acute Lymphoblastic LeukemiaB Lymphoblastic LymphomaCentral Nervous System LeukemiaMixed Phenotype Acute LeukemiaTesticular Leukemia

Investigational drug(s) / intervention(s)

Biospecimen CollectionBlinatumomab →Bone Marrow AspirationBone Marrow BiopsyBone ScanCalaspargase Pegol →Computed TomographyCyclophosphamide →Cytarabine →Daunorubicin Hydrochloride →Dexamethasone →Doxorubicin Hydrochloride →Inotuzumab Ozogamicin →Leucovorin Calcium →Magnetic Resonance ImagingMercaptopurine →Methotrexate →Pegaspargase →Positron Emission TomographyPrednisolone →Prednisone →Questionnaire AdministrationRadiation TherapyRadiation TherapyThioguanine →Vincristine Sulfate →

Biospecimen Collection: Undergo blood sample collection

Blinatumomab: Given IV

Bone Marrow Aspiration: Undergo bone marrow aspiration

Bone Marrow Biopsy: Undergo bone marrow biopsy

Bone Scan: Undergo bone scan

Calaspargase Pegol: Given IV

Computed Tomography: Undergo CT

Cyclophosphamide: Given IV

Cytarabine: Given IV, IT, or SC

Daunorubicin Hydrochloride: Given IV

Dexamethasone: Given PO or IV

Doxorubicin Hydrochloride: Given IV

Inotuzumab Ozogamicin: Given IV

Leucovorin Calcium: Given PO or IV

Magnetic Resonance Imaging: Undergo MRI

Mercaptopurine: Given PO

Methotrexate: Given IT or IV

Pegaspargase: Given IV or IM

Positron Emission Tomography: Undergo PET

Prednisolone: Given PO or IV

Prednisone: Given PO or IV

Questionnaire Administration: Ancillary studies

Radiation Therapy: Undergo testicular radiation therapy

Radiation Therapy: Undergo cranial radiation therapy

Thioguanine: Given PO

Vincristine Sulfate: Given IV

Study summary

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy and immunotherapy (chemo-immunotherapy) for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. Inotuzumab ozogamicin is a monoclonal antibody, which is a type of protein that can bind to certain targets on the surface of cells. Inotuzumab ozogamicin is a monoclonal antibody that is linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells by binding to the CD22 protein on the surface of the cancer cell and delivering calicheamicin inside the cells to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Blinatumomab is a specialized type of monoclonal antibody known as a bispecific T-cell engager (BiTE). It works by simultaneously binding to CD19 on cancer cells and CD3 on normal immune cells, bringing them together to destroy leukemia cells. Blinatumomab is a standard part of chemo-immunotherapy treatment for B-ALL. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin or blinatumomab.

The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemo-immunotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first phase of therapy: Induction. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-induction treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (consolidation, blinatumomab block 1, interim maintenance 1, blinatumomab block 2, delayed intensification, interim maintenance 2, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of consolidation or part of delayed intensification. Other aims of this study include evaluating 1) side effects of treatment using patient-reported outcomes and health-related quality of life, 2) the best ways to help patients adhere to oral chemotherapy regimens, 3) the relationship between levels of inotuzumab ozogamicin in the blood and side effects, 4) the impact of chemo-immunotherapy on the immune system and risk of infection, and 5) the impact of social determinants of health on outcomes. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

Eligibility

Sex
ALL
Min age
365 Days
Max age
25 Years
Healthy volunteers
No
Inclusion Criteria: * 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 * Initial white blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy): * Age 1-9.99 years: WBC \>= 50,000/uL * Age 10-24.99 years: Any WBC * Age 1-9.99 years: WBC \< 50,000/uL with one or more of the following: * Testicular leukemia * CNS leukemia (CNS3) * Steroid pretreatment. * Initial white blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy): * Age 1-24.99 years: any WBC NOTE: Patients enrolled as suspected MPAL but found on central confirmatory testing to have B-ALL must meet the B-ALL criteria above (age, WBC, extramedullary disease, steroid pretreatment) to switch to the B-ALL stratum before the end of induction. * Patient has newly diagnosed B-ALL or MPAL (by World Health Organization \[WHO\] 2016 criteria) with \>= 25% 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/uL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed. * Patient has newly diagnosed B-LLy Murphy stages III or IV. * Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment. * Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted. * Central nervous system (CNS) status must be determined prior to enrollment based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment and cytoreduction. Note that once cerebrospinal fluid (CSF) has been collected, protocol therapy can be initiated while final determination of CNS status is pending. It is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. This is allowed prior to enrollment. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy. * Direct bilirubin \< 2.0 mg/dL (34 micromoles/L) * Alanine aminotransferase (ALT) ≤ 10x upper limit of normal (ULN). For the purposes of this study, the ULN for ALT is defined as 45 U/L * Exceptions to this include patients with known Gilbert's Syndrome, or those with hepatic involvement from leukemic or lymphomatous infiltration * All patients and/or their parents or legal guardians must sign a written informed consent. * All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met. Exclusion Criteria: * Patients with Down syndrome are not eligible * With the exception of steroid pretreatment and steroid cytoreduction 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. * Patients who have received \> 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy. * Patients with 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 \> 1,000/uL circulating leukemia cells. * Patients with acute undifferentiated leukemia (AUL) are not eligible. * For 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. * Patients with known Charcot-Marie-Tooth disease. * Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype. * Patients requiring radiation at diagnosis. * Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential. * Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin. * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males.

Primary outcome measure(s)

Trial sites (231)

FacilityCityRegionStatus
Children's Hospital of Alabama Birmingham Alabama Recruiting
USA Health Strada Patient Care Center Mobile Alabama Recruiting
Providence Alaska Medical Center Anchorage Alaska Recruiting
Banner Children's at Desert Mesa Arizona Recruiting
Phoenix Childrens Hospital Phoenix Arizona Recruiting
Banner University Medical Center - Tucson Tucson Arizona Recruiting
Arkansas Children's Hospital Little Rock Arkansas Recruiting
Kaiser Permanente Downey Medical Center Downey California Recruiting
City of Hope Comprehensive Cancer Center Duarte California Recruiting
Loma Linda University Medical Center Loma Linda California Recruiting
Miller Children's and Women's Hospital Long Beach Long Beach California Recruiting
Children's Hospital Los Angeles Los Angeles California Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
Mattel Children's Hospital UCLA Los Angeles California Suspended
Valley Children's Hospital Madera California Recruiting
UCSF Benioff Children's Hospital Oakland Oakland California Recruiting
Kaiser Permanente-Oakland Oakland California Recruiting
Children's Hospital of Orange County Orange California Recruiting
Lucile Packard Children's Hospital Stanford University Palo Alto California Recruiting
Sutter Medical Center Sacramento Sacramento California Recruiting
University of California Davis Comprehensive Cancer Center Sacramento California Recruiting
Rady Children's Hospital - San Diego San Diego California Recruiting
Naval Medical Center -San Diego San Diego California Recruiting
UCSF Medical Center-Mission Bay San Francisco California Recruiting
Santa Barbara Cottage Hospital Santa Barbara California Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California Active Not Recruiting
Children's Hospital Colorado Aurora Colorado Recruiting
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado Recruiting
Connecticut Children's Medical Center Hartford Connecticut Recruiting
Yale University New Haven Connecticut Recruiting
Alfred I duPont Hospital for Children Wilmington Delaware Recruiting
MedStar Georgetown University Hospital Washington D.C. District of Columbia Suspended
Children's National Medical Center Washington D.C. District of Columbia Recruiting
Broward Health Medical Center Fort Lauderdale Florida Recruiting
Golisano Children's Hospital of Southwest Florida Fort Myers Florida Recruiting
UF Health Cancer Institute - Gainesville Gainesville Florida Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida Recruiting
Nemours Children's Clinic-Jacksonville Jacksonville Florida Recruiting
Palms West Radiation Therapy Loxahatchee Groves Florida Active Not Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida Recruiting

+ 191 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03959085 on ClinicalTrials.gov ↗ ← All trials in Canada