Clinical trialNCT05303792Active, not recruitingPhase 2Interventional

Comparing Inotuzumab Combined With Low Intensity Chemotherapy Plus Blinatumomab to Usual Chemotherapy Plus Blinatumomab in Older Adults With CD22+ B-cell Acute Lymphoblastic Leukemia

SponsorAlliance for Clinical Trials in OncologyEnrollment68B Acute Lymphoblastic LeukemiaB Lymphoblastic Lymphoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase II trial compares the combination of inotuzumab ozogamicin and low intensity chemotherapy and blinatumomab to the usual chemotherapy with blinatumomab 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. A monoclonal antibody, such as blinatumomab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving inotuzumab ozogamicin with chemotherapy and blinatumomab may help shrink the cancer and stop it from returning.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Marlise R. Luskin, MD, MSCE
Dana-Farber Cancer Institute
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

72 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

San Juan City Hospital
San Juan, Puerto Rico

United States

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Uci Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Uc Irvine Health/chao Family Comprehensive Cancer Center
Orange, California, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Yale University
New Haven, Connecticut, United States
Emory University Hospital/winship Cancer Institute
Atlanta, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Luke'S Cancer Institute - Boise
Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States
Kootenai Health - Coeur D'Alene
Coeur d'Alene, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Northshore University Healthsystem-Evanston Hospital
Evanston, Illinois, United States
Northshore University Healthsystem-Glenbrook Hospital
Glenview, Illinois, United States
Northshore University Healthsystem-Highland Park Hospital
Highland Park, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Uc Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States
Memorial Hospital East
Shiloh, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Norton Suburban Hospital and Medical Campus
Louisville, Kentucky, United States
University of Maryland/greenebaum Cancer Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
Siteman Cancer Center-South County
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Logan Health Medical Center
Kalispell, Montana, United States

32 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cyclophosphamide →Cytarabine →Dexamethasone →Doxorubicin →Inotuzumab ozogamicin →Mercaptopurine →Methotrexate →Methylprednisolone →Prednisone →Rituximab →Vincristine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 9 Jun 2023
Primary completion: 1 Apr 2027
Completion: 31 May 2029
Last update posted: 10 Jul 2026
Registered enrollment: 68
Registry id: NCT05303792

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.