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NCT05303792 · ClinicalTrials.gov registry record · Phase 2
Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma
A Phase 2 study of B Acute Lymphoblastic Leukemia and B Lymphoblastic Lymphoma, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 20
- Study locations
NCT05303792 is a Phase 2 study of B Acute Lymphoblastic Leukemia and B Lymphoblastic Lymphoma that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 68 participants, below the 1,024-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT05303792, a Phase 2 study of B Acute Lymphoblastic Leukemia and B Lymphoblastic Lymphoma, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug, called CalichDMH. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers CalichDMH to kill them. Chemotherapy drugs 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. Giving inotuzumab ozogamicin with chemotherapy may help shrink the cancer and stop it from returning.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Dexamethasone
- DRUG Vincristine
- BIOLOGICAL Inotuzumab Ozogamicin
- DRUG Methotrexate
Study Locations (20)
Idaho
- Saint Alphonsus Cancer Care Center-Boise - Boise
- Saint Luke's Cancer Institute - Boise - Boise
- Saint Alphonsus Cancer Care Center-Caldwell - Caldwell
- Kootenai Health - Coeur d'Alene - Coeur d'Alene
- Saint Alphonsus Cancer Care Center-Nampa - Nampa
- Kootenai Clinic Cancer Services - Post Falls - Post Falls
- Kootenai Clinic Cancer Services - Sandpoint - Sandpoint
Illinois
- Northwestern University - Chicago
- University of Chicago Comprehensive Cancer Center - Chicago
- NorthShore University HealthSystem-Evanston Hospital - Evanston
- NorthShore University HealthSystem-Glenbrook Hospital - Glenview
- NorthShore University HealthSystem-Highland Park Hospital - Highland Park
- Loyola University Medical Center - Maywood
- UC Comprehensive Cancer Center at Silver Cross - New Lenox
California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Stanford Cancer Institute Palo Alto - Palo Alto
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Connecticut
- Yale University - New Haven
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2023-06-09 |
| Est. Completion | 2028-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05303792
The ClinicalTrials.gov registry entry for NCT05303792 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,024-participant average among 20 other B Acute Lymphoblastic Leukemia trials with a reported enrollment target (93% lower). The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with B Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05303792 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Idaho, Illinois, California.
Frequently Asked Questions
What is clinical trial NCT05303792 about?
NCT05303792 is a clinical study titled "Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma". This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug, called...
What is the current status of trial NCT05303792?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2023-06-09. Estimated completion is 2028-05.
What conditions does trial NCT05303792 study?
This clinical trial studies the following conditions: B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma.
What interventions are being tested in trial NCT05303792?
The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Vincristine (DRUG), Inotuzumab Ozogamicin (BIOLOGICAL), Methotrexate (DRUG).
Who is sponsoring clinical trial NCT05303792?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05303792 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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