Actively Recruiting
Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
Led by Children's Oncology Group ยท Updated on 2026-05-04
80
Participants Needed
157
Research Sites
497 weeks
Total Duration
On this page
Sponsors
C
Children's Oncology Group
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.
CONDITIONS
Official Title
Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 1 year or older and younger than 22 years at enrollment
- Patients must have B-ALL or previously diagnosed B lymphoblastic lymphoma with at least 5% bone marrow blasts
- Relapsed patients with B-lymphoblastic lymphoma are eligible if marrow blasts are at least 5%
- Patients with M2 marrow morphology must have confirmatory testing showing 5% or more blasts
- Leukemic blasts must show CD22 surface expression by flow cytometry or biopsy
- Patients must have second or greater relapse, primary refractory disease with at least 2 prior inductions, first relapse refractory to one prior re-induction, or any relapse after stem cell transplant (Cohort 1)
- Patients with Down syndrome are eligible for Cohort 1 under specific conditions
- Patients with Philadelphia chromosome positive ALL must have had two prior therapy attempts including two different TKIs
- Patients must have recovered from acute toxic effects of all prior anti-cancer therapy
- Specific waiting periods apply after certain chemotherapies, antibodies, corticosteroids, radiotherapy, stem cell transplant, and CAR T cell therapy
- Patients must have adequate kidney function and liver enzymes within defined limits
- Performance status must correspond to ECOG 0, 1, or 2
You will not qualify if you...
- Patients with any prior history of sinusoidal obstruction syndrome
- Patients with isolated central nervous system, testicular, or other extramedullary relapse
- Patients previously treated with inotuzumab ozogamicin
- Patients with prior stem cell transplant (Cohort 2 only)
- Patients with Down syndrome (Cohort 2 only)
- History of allergic reaction to similar compounds unless Erwinia asparaginase is available (Cohort 2)
- Patients with active optic nerve or retinal involvement
- Patients currently receiving another investigational drug
- Patients receiving or planning to receive other anti-cancer agents except certain allowed medications
- Patients receiving anti-GVHD or organ rejection prevention agents
- Patients receiving corticosteroids except under specified conditions
- Patients with known HIV, hepatitis B or C infections
- Patients with active uncontrolled infections or certain genetic syndromes
- Pregnant or breastfeeding females, or those unwilling to use contraception as required
- Men unwilling to use contraception as required
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 157 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
Actively Recruiting
3
Banner Children's at Desert
Mesa, Arizona, United States, 85202
Actively Recruiting
4
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
5
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
Active, Not Recruiting
6
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
Actively Recruiting
7
Kaiser Permanente Downey Medical Center
Downey, California, United States, 90242
Actively Recruiting
8
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Active, Not Recruiting
9
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Suspended
10
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
11
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
12
Valley Children's Hospital
Madera, California, United States, 93636
Active, Not Recruiting
13
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
14
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Actively Recruiting
15
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
16
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
17
Sutter Medical Center Sacramento
Sacramento, California, United States, 95816
Actively Recruiting
18
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
19
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
Actively Recruiting
20
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
21
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Active, Not Recruiting
22
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
23
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States, 80218
Actively Recruiting
24
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
25
Yale University
New Haven, Connecticut, United States, 06520
Active, Not Recruiting
26
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
27
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
28
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Actively Recruiting
29
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Active, Not Recruiting
30
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
31
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
32
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
33
AdventHealth Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
34
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Actively Recruiting
35
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
Actively Recruiting
36
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Active, Not Recruiting
37
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
38
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States, 33607
Suspended
39
Saint Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Actively Recruiting
40
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
41
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Actively Recruiting
42
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
43
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States, 83712
Actively Recruiting
44
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
45
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
46
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
47
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Actively Recruiting
48
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
49
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
50
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
Active, Not Recruiting
51
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Actively Recruiting
52
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
53
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
54
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
55
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
Actively Recruiting
56
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Actively Recruiting
57
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Actively Recruiting
58
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074
Actively Recruiting
59
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
60
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
61
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Active, Not Recruiting
62
Tufts Children's Hospital
Boston, Massachusetts, United States, 02111
Active, Not Recruiting
63
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
64
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
Actively Recruiting
65
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
66
Michigan State University
East Lansing, Michigan, United States, 48823
Active, Not Recruiting
67
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
68
Corewell Health Children's
Royal Oak, Michigan, United States, 48073
Actively Recruiting
69
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
70
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
71
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
72
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
73
University of Missouri Children's Hospital
Columbia, Missouri, United States, 65212
Actively Recruiting
74
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
75
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States, 63104
Actively Recruiting
76
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
77
Mercy Hospital Saint Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
78
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
Actively Recruiting
79
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
80
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
Actively Recruiting
81
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States, 89135
Actively Recruiting
82
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States, 89144
Actively Recruiting
83
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
84
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
85
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
86
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
87
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
88
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
89
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
90
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
Actively Recruiting
91
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
92
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Actively Recruiting
93
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
94
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
95
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Actively Recruiting
96
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
97
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
98
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
99
University of Rochester
Rochester, New York, United States, 14642
Active, Not Recruiting
100
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
101
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
102
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
103
New York Medical College
Valhalla, New York, United States, 10595
Active, Not Recruiting
104
Mission Hospital
Asheville, North Carolina, United States, 28801
Actively Recruiting
105
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Active, Not Recruiting
106
Duke University Medical Center
Durham, North Carolina, United States, 27710
Suspended
107
East Carolina University
Greenville, North Carolina, United States, 27834
Suspended
108
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
109
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
110
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Actively Recruiting
111
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
112
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Active, Not Recruiting
113
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
114
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Actively Recruiting
115
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
116
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
117
Legacy Emanuel Children's Hospital
Portland, Oregon, United States, 97227
Actively Recruiting
118
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
119
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
120
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
121
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
122
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
123
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Actively Recruiting
124
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
125
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
126
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
127
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
128
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
Actively Recruiting
129
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
130
T C Thompson Children's Hospital
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
131
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States, 37916
Actively Recruiting
132
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
133
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States, 37203
Actively Recruiting
134
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
135
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Actively Recruiting
136
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Actively Recruiting
137
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Actively Recruiting
138
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
139
El Paso Children's Hospital
El Paso, Texas, United States, 79905
Actively Recruiting
140
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
141
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
142
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Actively Recruiting
143
UMC Cancer Center / UMC Health System
Lubbock, Texas, United States, 79415
Actively Recruiting
144
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
145
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
Actively Recruiting
146
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
147
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Suspended
148
University of Vermont and State Agricultural College
Burlington, Vermont, United States, 05405
Actively Recruiting
149
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
150
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Actively Recruiting
151
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Actively Recruiting
152
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
153
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Actively Recruiting
154
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Actively Recruiting
155
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Active, Not Recruiting
156
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Active, Not Recruiting
157
HIMA San Pablo Oncologic Hospital
Caguas, Puerto Rico, 00726
Active, Not Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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