Actively Recruiting
Study to Test OBI-3424 in Patients With T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LBL)
Led by SWOG Cancer Research Network · Updated on 2025-08-15
67
Participants Needed
163
Research Sites
390 weeks
Total Duration
On this page
Sponsors
S
SWOG Cancer Research Network
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I/II trial studies the safety, side effects and best dose of OBI-3424 and how well it works in treating patients with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Chemotherapy drugs, such as OBI-3424, 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. OBI-3424 may reduce the amount of leukemia in the body.
CONDITIONS
Official Title
Study to Test OBI-3424 in Patients With T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LBL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma with at least 5% lymphoblasts in bone marrow or blood
- Presence of acute leukemia with 5% or more lymphoblasts in peripheral blood or bone marrow within 14 days before registration
- Patients 18 years or older must be refractory or relapsed after standard induction chemotherapy; patients under 18 must be relapsed or refractory after two or more chemotherapy cycles
- No evidence of central nervous system disease within 28 days before registration; lumbar puncture negative if symptoms present
- Patients may have received prior nelarabine therapy under specific conditions
- No chemotherapy or investigational agents within 14 days prior to registration except certain medications
- No allogeneic hematopoietic transplant within 90 days before registration
- No active grade 2 or higher acute graft versus host disease or moderate/severe chronic graft versus host disease
- Age 12 years or older
- Zubrod Performance Status 0-3 for patients 16 years or older; Lansky score 50 or greater for patients under 16
- No uncontrolled systemic infections within 14 days before registration
- Adequate kidney and liver function within 14 days prior to registration according to specified laboratory criteria
- Ability to safely stop certain medications before and after OBI-3424 doses
- Patients with HIV, hepatitis B, or hepatitis C may be eligible under controlled conditions
- No known prolonged QT interval on ECG
- Not pregnant or nursing; females of reproductive potential must have negative pregnancy test and agree to effective contraception
- No other active malignancies requiring systemic treatment within 6 months
- Agreement to provide bone marrow and blood specimens for testing and consent to specimen banking
- Informed consent provided according to regulations
- Slot reservation required for phase I enrollment
You will not qualify if you...
- Evidence of central nervous system disease classified as CNS3
- Active grade 2 or higher acute graft versus host disease or moderate/severe chronic graft versus host disease
- History of extensive graft versus host disease within 90 days prior to registration
- Chemotherapy or investigational agents within 14 days prior to registration except specified medications
- Allogeneic hematopoietic transplant within 90 days prior to registration
- Uncontrolled systemic fungal, bacterial, viral or other infection within 14 days prior to registration
- Known prolonged QT interval above defined limits
- Pregnant or nursing females
- Other active malignancies requiring systemic treatment within 6 months prior to registration
- Receiving antiviral therapies that are strong inhibitors or inducers of CYP3A4
- Inability to safely discontinue use of strong inhibitors or inducers of CYP3A4 or naproxen before and after OBI-3424 dosing
- Patients not able to provide informed consent or without legally authorized representatives to consent if under 18 or impaired decision making
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 163 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Active, Not Recruiting
2
Kingman Regional Medical Center
Kingman, Arizona, United States, 86401
Actively Recruiting
3
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
Actively Recruiting
4
PCR Oncology
Arroyo Grande, California, United States, 93420
Actively Recruiting
5
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
6
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Actively Recruiting
7
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
8
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
9
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
10
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Actively Recruiting
11
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
12
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
13
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
14
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
15
Augusta University Medical Center
Augusta, Georgia, United States, 30912
Actively Recruiting
16
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, United States, 60527
Active, Not Recruiting
17
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
18
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
19
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
20
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Active, Not Recruiting
21
Loyola Medicine Homer Glen
Homer Glen, Illinois, United States, 60491
Active, Not Recruiting
22
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Active, Not Recruiting
23
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Active, Not Recruiting
24
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, United States, 60160
Active, Not Recruiting
25
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Active, Not Recruiting
26
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Active, Not Recruiting
27
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
28
Mary Greeley Medical Center
Ames, Iowa, United States, 50010
Actively Recruiting
29
McFarland Clinic - Ames
Ames, Iowa, United States, 50010
Actively Recruiting
30
McFarland Clinic - Boone
Boone, Iowa, United States, 50036
Actively Recruiting
31
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States, 50501
Actively Recruiting
32
McFarland Clinic - Jefferson
Jefferson, Iowa, United States, 50129
Actively Recruiting
33
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States, 50158
Actively Recruiting
34
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
35
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, United States, 70805
Actively Recruiting
36
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
37
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
38
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Actively Recruiting
39
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Active, Not Recruiting
40
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
Active, Not Recruiting
41
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
42
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
43
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
44
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
45
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
46
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, United States, 49009
Actively Recruiting
47
Beacon Kalamazoo
Kalamazoo, Michigan, United States, 49048
Actively Recruiting
48
Trinity Health Muskegon Hospital
Muskegon, Michigan, United States, 49444
Actively Recruiting
49
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, United States, 49120
Actively Recruiting
50
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, United States, 49444
Actively Recruiting
51
Corewell Health Reed City Hospital
Reed City, Michigan, United States, 49677
Actively Recruiting
52
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Actively Recruiting
53
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, United States, 49085
Actively Recruiting
54
Munson Medical Center
Traverse City, Michigan, United States, 49684
Actively Recruiting
55
University of Michigan Health - West
Wyoming, Michigan, United States, 49519
Actively Recruiting
56
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Active, Not Recruiting
57
Minnesota Oncology - Burnsville
Burnsville, Minnesota, United States, 55337
Active, Not Recruiting
58
Cambridge Medical Center
Cambridge, Minnesota, United States, 55008
Active, Not Recruiting
59
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Active, Not Recruiting
60
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Active, Not Recruiting
61
Unity Hospital
Fridley, Minnesota, United States, 55432
Active, Not Recruiting
62
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, United States, 55369
Active, Not Recruiting
63
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Active, Not Recruiting
64
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Active, Not Recruiting
65
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Active, Not Recruiting
66
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Active, Not Recruiting
67
Health Partners Inc
Minneapolis, Minnesota, United States, 55454
Active, Not Recruiting
68
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
69
Monticello Cancer Center
Monticello, Minnesota, United States, 55362
Active, Not Recruiting
70
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
Active, Not Recruiting
71
Fairview Northland Medical Center
Princeton, Minnesota, United States, 55371
Active, Not Recruiting
72
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Active, Not Recruiting
73
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Active, Not Recruiting
74
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Active, Not Recruiting
75
United Hospital
Saint Paul, Minnesota, United States, 55102
Active, Not Recruiting
76
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Active, Not Recruiting
77
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Active, Not Recruiting
78
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Active, Not Recruiting
79
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Active, Not Recruiting
80
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
Active, Not Recruiting
81
Fairview Lakes Medical Center
Wyoming, Minnesota, United States, 55092
Active, Not Recruiting
82
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
83
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
Actively Recruiting
84
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
85
Carson Tahoe Regional Medical Center
Carson City, Nevada, United States, 89703
Actively Recruiting
86
Cancer and Blood Specialists-Henderson
Henderson, Nevada, United States, 89052
Actively Recruiting
87
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, United States, 89052
Actively Recruiting
88
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, United States, 89052
Actively Recruiting
89
Las Vegas Cancer Center-Henderson
Henderson, Nevada, United States, 89052
Suspended
90
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, United States, 89052
Actively Recruiting
91
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, United States, 89074
Actively Recruiting
92
GenesisCare USA - Henderson
Henderson, Nevada, United States, 89074
Actively Recruiting
93
Las Vegas Urology - Green Valley
Henderson, Nevada, United States, 89074
Actively Recruiting
94
Las Vegas Urology - Pebble
Henderson, Nevada, United States, 89074
Actively Recruiting
95
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, United States, 89074
Actively Recruiting
96
Las Vegas Urology - Pecos
Las Vegas, Nevada, United States, 89074
Actively Recruiting
97
Desert West Surgery
Las Vegas, Nevada, United States, 89102
Suspended
98
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, United States, 89102
Actively Recruiting
99
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Actively Recruiting
100
Hope Cancer Care of Nevada
Las Vegas, Nevada, United States, 89103
Actively Recruiting
101
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, United States, 89106
Actively Recruiting
102
Urology Specialists of Nevada - Central
Las Vegas, Nevada, United States, 89106
Actively Recruiting
103
GenesisCare USA - Las Vegas
Las Vegas, Nevada, United States, 89109
Actively Recruiting
104
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, United States, 89109
Suspended
105
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
Actively Recruiting
106
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, United States, 89113
Suspended
107
Las Vegas Prostate Cancer Center
Las Vegas, Nevada, United States, 89113
Actively Recruiting
108
Las Vegas Urology - Sunset
Las Vegas, Nevada, United States, 89113
Actively Recruiting
109
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, United States, 89113
Actively Recruiting
110
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, United States, 89119
Actively Recruiting
111
Ann M Wierman MD LTD
Las Vegas, Nevada, United States, 89128
Actively Recruiting
112
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, United States, 89128
Actively Recruiting
113
GenesisCare USA - Vegas Tenaya
Las Vegas, Nevada, United States, 89128
Actively Recruiting
114
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, United States, 89128
Suspended
115
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, United States, 89128
Actively Recruiting
116
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, United States, 89128
Actively Recruiting
117
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, United States, 89128
Actively Recruiting
118
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, United States, 89128
Actively Recruiting
119
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States, 89135
Actively Recruiting
120
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, United States, 89144
Actively Recruiting
121
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, United States, 89144
Actively Recruiting
122
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States, 89144
Actively Recruiting
123
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, United States, 89148-2405
Suspended
124
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Actively Recruiting
125
GenesisCare USA - Fort Apache
Las Vegas, Nevada, United States, 89148
Actively Recruiting
126
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, United States, 89148
Actively Recruiting
127
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, United States, 89149
Suspended
128
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States, 89169
Actively Recruiting
129
University Cancer Center
Las Vegas, Nevada, United States, 89169
Actively Recruiting
130
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, United States, 89048
Actively Recruiting
131
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
132
Saint Mary's Regional Medical Center
Reno, Nevada, United States, 89503
Actively Recruiting
133
Radiation Oncology Associates
Reno, Nevada, United States, 89509
Actively Recruiting
134
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
135
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Active, Not Recruiting
136
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
137
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
138
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
139
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
140
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
141
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Suspended
142
Oregon Health and Science University
Portland, Oregon, United States, 97239
Active, Not Recruiting
143
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
144
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
145
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
146
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
147
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States, 37203
Actively Recruiting
148
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Actively Recruiting
149
El Paso Children's Hospital
El Paso, Texas, United States, 79905
Actively Recruiting
150
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
Actively Recruiting
151
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
152
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
153
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
154
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Actively Recruiting
155
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
156
Overlake Medical Center
Bellevue, Washington, United States, 98004
Suspended
157
Valley Medical Center
Renton, Washington, United States, 98055
Actively Recruiting
158
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
159
University of Washington Medical Center - Montlake
Seattle, Washington, United States, 98195
Actively Recruiting
160
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
Actively Recruiting
161
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Actively Recruiting
162
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Active, Not Recruiting
163
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
Active, Not Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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