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NCT03959085 · ClinicalTrials.gov registry record · Phase 3
Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
A Phase 3 study of Mixed Phenotype Acute Leukemia and B Acute Lymphoblastic Leukemia, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 5,951
- Enrollment target
- 20
- Study locations
NCT03959085 is a Phase 3 study of Mixed Phenotype Acute Leukemia and B Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 5,951 participants, above the 194-participant average among 29 other Mixed Phenotype Acute Leukemia trials with a reported enrollment target (2968% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT03959085, a Phase 3 study of Mixed Phenotype Acute Leukemia and B Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 5,951 participants
- Enrollment target
- 20
- Study locations
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
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Bone Scan
- BIOLOGICAL Blinatumomab
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Sutter Medical Center Sacramento - Sacramento
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Alabama
- Children's Hospital of Alabama - Birmingham
- USA Health Strada Patient Care Center - Mobile
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,951 participants |
| Start Date | 2019-10-31 |
| Est. Completion | 2032-03-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03959085
The ClinicalTrials.gov registry entry for NCT03959085 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 5,951 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 194-participant average among 29 other Mixed Phenotype Acute Leukemia trials with a reported enrollment target (2968% higher). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Mixed Phenotype Acute Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03959085 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT03959085 about?
NCT03959085 is a clinical study titled "Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy". 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 protei...
What is the current status of trial NCT03959085?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 5,951 participants. The study started on 2019-10-31. Estimated completion is 2032-03-31.
What conditions does trial NCT03959085 study?
This clinical trial studies the following conditions: Mixed Phenotype Acute Leukemia, B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Central Nervous System Leukemia, Testicular Leukemia.
What interventions are being tested in trial NCT03959085?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Bone Scan (PROCEDURE), Blinatumomab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03959085?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03959085 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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