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
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.
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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