Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
NCT ID: NCT03739814
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE2
64 participants
INTERVENTIONAL
2019-05-08
2027-02-01
Brief Summary
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Detailed Description
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I. To confirm tolerability of the combination regimen of inotuzumab ozogamicin followed by blinatumomab.
II. To estimate the 1-year event-free survival of older, transplant-ineligible patients with newly diagnosed, Philadelphia (Ph)-negative, CD22-positive, B-cell acute lymphoblastic leukemia (ALL) treated with inotuzumab ozogamicin induction followed by blinatumomab consolidation. (Cohort 1) III. To estimate the 1-year event-free survival of patients with relapsed or refractory Ph-negative, CD22-positive, B-cell ALL treated with inotuzumab ozogamicin induction followed by blinatumomab consolidation. (Cohort 2)
SECONDARY OBJECTIVES:
I. To estimate the median, 1-year, and 3-year overall survival (OS) in all eligible patients. (Cohort 1) II. To estimate the median, 1-year, and 3-year relapse-free survival (RFS) in all eligible patients. (Cohort 1) III. To estimate the median and 3-year event-free survival (EFS) in all eligible patients. (Cohort 1) IV. To estimate the complete response (CR) rate and overall response rate (ORR, defined as complete response \[CR\] + complete response with incomplete count recovery \[CRi\]) to inotuzumab ozogamicin followed by blinatumomab (regimen CR rate and ORR). (Cohort 1) V. To estimate the CR rate and ORR (CR + CRi) to inotuzumab ozogamicin induction alone (induction CR and ORR). (Cohort 1) VI. To estimate the minimal residual disease (MRD) negativity rate in subjects achieving a CR or CRi. (Cohort 1) VII. To estimate the treatment-related mortality with this regimen. (Cohort 1) VIII. To describe the safety and tolerability of this regimen. (Cohort 1) IX. To estimate the median, 1-year, and 3-year OS in all eligible patients. (Cohort 2) X. To estimate the median, 1-year, and 3-year RFS in all eligible patients. (Cohort 2) XI. To estimate the median and 3-year EFS in all eligible patients. (Cohort 2) XII. To estimate ORR (CR/CRi and CR/complete response with partial hematologic recovery \[CRh\]) to blinatumomab in patients with ALL refractory to inotuzumab ozogamicin. (Cohort 2) XIII. To estimate the CR, CRi, and CRh rates at defined time points and cumulatively for the entire regimen. (Cohort 2) XIV. To determine the MRD negativity (\< 10\^-4) rate at defined time points including prior to allogeneic HCT and cumulatively in patients achieving a CR, CRh, or CRi. (Cohort 2) XV. To determine the allogeneic hematopoietic cell transplantation (HCT) rate in eligible subjects. (Cohort 2) XVI. To estimate the treatment-related mortality with this regimen. (Cohort 2) XVII. To describe the safety and tolerability of this regimen. (Cohort 2)
OTHER OBJECTIVES:
I. Results of the primary analysis will be examined for consistency, while accounting for the stratification factors and/or covariates of baseline quality of life (QOL) and fatigue.
CORRELATIVE SCIENCE OBJECTIVES:
I. To correlate specific karyotype groups (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters.
II. To correlate specific karyotype groups with response rates, response duration, survival, and cure in patients treated with inotuzumab ozogamicin followed by blinatumomab.
III. To correlate specific karyotype groups with MRD. IV. To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse.
V. To assess the correlation of quantitative MRD post-induction with inotuzumab ozogamicin and at sequential consolidation time points with blinatumomab with RFS, EFS, and OS.
VI. To correlate the influence of MRD status (detectable versus \[vs.\] not and as a continuous measure) in relation to EFS, RFS, and OS with other clinical and biological factors (e.g. previously untreated vs. relapsed disease cohorts; age, initial white blood cell \[WBC\] count, cytogenetics).
VII. To identify genetic variants and predictors of ex vivo resistance. VIII. To identify genetic variants and predictors of MRD. IX. To identify genetic variants and predictors of relapse. X. To determine inter-patient variability in drug sensitivity of adult ALL. XI. To examine the associations of drug sensitivity with host and leukemia molecular features.
EXPLORATORY OBJECTIVES:
I. To estimate the median, 1-year, and 3-year RFS, EFS, and OS in patients achieving a CR/CRi to inotuzumab ozogamicin. (Cohort 1) II. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving MRD-negative vs. MRD-positive CR/CRi to inotuzumab ozogamicin. (Cohort 1) III. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving MRD-negative vs. MRD-positive CR/CRi at any time. (Cohort 1) IV. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 1) V. To estimate the rate of cytokine release syndrome in this population. (Cohort 1) VI. To estimate the median, 1-year, and 3-year RFS from time of CR/CRi to inotuzumab ozogamicin in patients receiving inotuzumab ozogamicin followed by blinatumomab and not undergoing allogeneic hematopoietic cell transplantation (HCT). (Cohort 2) VII. To estimate median, 1-year, and 3-year OS after CR/CRi to inotuzumab ozogamicin in patients not undergoing allogeneic HCT. (Cohort 2) VIII. To compare in a non-randomized fashion median, 1-year, and 3-year OS, median, 1-year, and 3-year RFS, cumulative incidence of relapse (CIR), and non-relapse mortality (NRM) between patients achieving CR/CRi and receiving consolidation with or without allogeneic HCT. (Cohort 2) IX. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 2) X. To estimate the rate of cytokine release syndrome in this population. (Cohort 2)
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT 1: Patients receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day 1, 8, and 15 (Course IA). By the end of Course IA (day 21), patients with adequate ALL cytoreduction continue to Course IB/IC, and patients who fail to achieve ALL cytoreduction continue to Course II. By the end of Course II, patients with CR-CRi to Course IB/IC and Course II continue to Course IIIA, patients without adequate ALL cytoreduction to Course IA or refractory to Course IB/IC but CR/CRi to Course II continue to Course IIIB.
COHORT 2: Patients receive inotuzumab ozogamicin IV over 1 hour on day 1, 8, and 15 (Course IA). By the end of Course IA (day 21), patients with adequate ALL cytoreduction continue to Course IB/IC, and patients who fail to achieve ALL cytoreduction continue to Course II. Patients with CR/CRi at the end of Course II continue to Course IIIB.
COURSE IB/IC: Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Treatment continues for 1 course (28 days) in the absence of disease progression or unacceptable toxicity.
COURSE II: Patients receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity.
COURSE IIIA: Patients receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity.
COURSE IIIB: Patients receive blinatumomab IV continuously on days 1-28, 43-70, and 85-112. Treatment continues for 1 course (126 days) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 3 years, and then every 6 months for up to 10 years.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 (inotuzumab ozogamicin, blinatumomab)
See Detailed Description
Blinatumomab
Given IV
Inotuzumab Ozogamicin
Given IV
Cohort 2 (inotuzumab ozogamicin, blinatumomab)
See Detailed Description.
Blinatumomab
Given IV
Inotuzumab Ozogamicin
Given IV
Interventions
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Blinatumomab
Given IV
Inotuzumab Ozogamicin
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Submission of bone marrow aspirate and peripheral blood for MRD analysis is mandatory prior to registration; the bone marrow sample should be from the first aspiration (i.e. first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be initiated as soon as possible after pre-registration. The specimens should be sent to the HEME Biobank.
* Lumbar Puncture (Spinal Tap) and Intrathecal Methotrexate:
* Patients may receive the day 1 of course IA dose of intrathecal (IT) methotrexate during the prior-to-registration lumbar puncture (or the venous line placement) to avoid a second lumbar puncture. If the dose is administered prior to registration, then systemic chemotherapy must begin within 7 days of this IT chemotherapy.
* Registration Eligibility Criteria (Step 1)
* Morphologic diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) based on World Health Organization (WHO) criteria. Patients with Burkitt lymphoma/leukemia are not eligible.
* CD22-positive disease defined as CD22 expression by \>= 20% of lymphoblasts by local hematopathology evaluation.
* Philadelphia chromosome/BCR-ABL1-negative ALL by cytogenetics, fluorescence in situ hybridization (FISH), and/or polymerase chain reaction (PCR). If any test is positive for Philadelphia chromosome/BCR-ABL1, then the patient is ineligible.
* No active central nervous system (CNS) leukemia (i.e. only CNS-1 disease allowed). Active CNS leukemia is defined as morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within 28 days prior to registration, symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurological dysfunction) within the 28 days prior to registration, and/or known asymptomatic parenchymal CNS mass lesions; see below for additional guidance. Prophylactic intrathecal medication alone is not an exclusion.
* Categories of CNS Involvement for CNS Evaluation Prior to Registration:
* CNS 1: CSF has \< 5 WBC/uL with cytospin negative for blasts; or \>= 10 red blood cell (RBC)/uL with cytospin negative for blasts.
* CNS 2: CSF has \< 5 WBC/uL with cytospin positive for blasts; or \>= 10 RBC/uL with cytospin positive for blasts; or \>= 10 RBC/uL, WBC/uL \>= 5 but less than Steinherz/Bleyer algorithm with cytospin positive for blasts (see below).
* CNS 3: CSF has \>= 5 WBC/uL with cytospin positive for blasts; or \>= 10 RBC/uL, \>= 5 WBC/uL and positive by Steinherz/Bleyer algorithm (see below); or clinical signs of CNS leukemia (such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome). Steinherz/Bleyer Method of Evaluating Initial Traumatic Lumbar Punctures:
* If the patient has leukemia cells in the peripheral blood and the lumbar puncture is traumatic and contains \>= 5 WBC/uL with blasts, the following algorithm should be used to define CNS disease: CSF WBC/CSF RBC \> 2 x (Blood WBC/Blood RBC count)
* Patients with known or suspected testicular involvement by leukemia are allowed provided that the patient receives concomitant scrotal/testicular radiotherapy.
* Unilateral or bilateral testicular enlargement should be assessed by ultrasound or other imaging technique. Biopsy is recommended if clinical findings are equivocal or suggestive of hydrocele or a non-leukemic mass, but further assessments are per treating physician discretion.
* Not pregnant and not nursing.
* This study involves agents that have known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required.
* Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
* No unstable cardiac disease such as myocardial infarction, angina pectoris, uncontrolled heart failure, or uncontrolled cardiac arrhythmia within 6 months of registration.
* No impaired cardiac function, defined as left ventricular ejection fraction (LVEF) \< 45% or New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF).
* Patients with known human immunodeficiency virus (HIV) infection are eligible if they have been on effective antiretroviral therapy with an undetectable viral load tested within 6 months of registration.
* Patients with hepatitis B virus (HBV) are eligible only if they meet all the following:
* On HBV-suppressive therapy.
* No evidence of active virus.
* No evidence of HBV-related liver damage.
* Patients with hepatitis C virus (HCV) are eligible only if they meet all the following:
* Successfully completed complete-eradication therapy with undetectable viral load.
* No evidence of HCV-related liver damage.
* No history of clinically relevant neurologic disorder such as epilepsy, seizure, aphasia, stroke, severe brain injury, structural brain abnormality, benign brain tumor, dementia, Parkinson's disease, movement disorder, cerebellar disease, or other significant CNS abnormalities.
* No prior additional malignancy (i.e. in addition to ALL) except adequately treated basal- or squamous-cell skin cancer, in situ cervical cancer, stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for \>= 2 years.
* No history of clinically significant ventricular arrhythmia, unexplained non-vasovagal syncope, or chronic bradycardic states such as sinoatrial block or higher degree of atrioventricular block unless a permanent pacemaker has been implanted.
* No history of chronic liver disease, including cirrhosis.
* No history of sinusoidal occlusion syndrome/veno-occlusive disease of the liver.
* No uncontrolled infection or recent history (within 4 months prior to registration) of deep tissue infections such as fasciitis or osteomyelitis.
* Total bilirubin, serum =\< 1.5 x upper limit of normal (ULN)\*
* Except in the event of: 1) Gilbert disease, in which case total bilirubin must be =\< 2 x ULN, or 2) elevated bilirubin believed by investigator to be due to leukemic infiltration, in which case total bilirubin must be =\< 2 x ULN.
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN
* Creatinine, serum =\< 1.5 ULN OR creatinine clearance \>= 40 mL/min
* QT interval by Fridericia's correction formula (QTcF) =\< 470 msec
* Cohort 1 Patients Only
* Age \>= 60 years.
* No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, and/or leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed therapy may be administered for no more than 14 days and must be completed \>= 24 hours prior to the initiation of protocol therapy.
* No plan for allogeneic or autologous hematopoietic cell transplantation (HCT).
* Cohort 2 Patients Only:
* Age \>= 18 years.
* Relapsed or refractory disease in salvage 1 or 2.
* No isolated extramedullary relapse.
* Prior allogeneic HCT permitted.
* Patients with prior allogeneic HCT must have completed transplantation \>= 4 months prior to registration.
* Patients with prior allogeneic HCT must have no evidence of graft-versus-host disease and must have completed immunosuppressive therapy \>= 30 days prior to registration.
* Prior treatment with inotuzumab ozogamicin, blinatumomab, other CD22-directed therapy, or other CD19-directed therapy is not allowed.
* Prior treatment with rituximab must be completed \>= 7 days prior to registration.
* Prior treatment with other monoclonal antibodies must be completed \>= 6 weeks prior to registration.
* Prior treatment for ALL must be completed \>= 14 days prior to registration with the following exceptions: intrathecal chemotherapy, hydroxyurea, corticosteroids, 6-mercaptopurine, methotrexate, vincristine, and/or leukapheresis to reduce circulating absolute lymphoblast count to =\< 10,000/uL or prevent complications related to ALL are allowed but must be completed \>= 24 hours prior to the initiation of protocol therapy.
* Patients should have resolution of any acute non-hematologic toxicities of prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 grade =\< 1.
* Peripheral blood absolute lymphoblast count =\< 10,000/uL (treatment allowed as above to reduce blast count to =\< 10,000/uL)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Matthew J Wieduwilt
Role: PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology
Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Kingman Regional Medical Center
Kingman, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
PCR Oncology
Arroyo Grande, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Community Cancer Institute
Clovis, California, United States
University Oncology Associates
Clovis, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
UC San Diego Moores Cancer Center
La Jolla, 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
Beebe Medical Center
Lewes, Delaware, United States
Beebe South Coastal Health Campus
Millville, Delaware, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
TidalHealth Nanticoke / Allen Cancer Center
Seaford, Delaware, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, United States
OSF Saint Anthony's Health Center
Alton, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
SIH Cancer Institute
Carterville, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Illinois CancerCare-Dixon
Dixon, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States
Loyola Medicine Homer Glen
Homer Glen, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Valley Radiation Oncology
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Springfield Memorial Hospital
Springfield, Illinois, United States
Illinois CancerCare - Washington
Washington, Illinois, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Mercy Medical Center
Springfield, Massachusetts, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States
Trinity Health Medical Center - Canton
Canton, Michigan, United States
Caro Cancer Center
Caro, Michigan, United States
Chelsea Hospital
Chelsea, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, United States
Newland Medical Associates-Clarkston
Clarkston, Michigan, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, United States
Henry Ford River District Hospital
East China Township, Michigan, United States
Cancer Hematology Centers - Flint
Flint, Michigan, United States
Genesee Hematology Oncology PC
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, United States
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, United States
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States
Hope Cancer Clinic
Livonia, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, United States
Henry Ford Warren Hospital - Breast Macomb
Macomb, Michigan, United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, United States
Hope Cancer Center
Pontiac, Michigan, United States
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, United States
Newland Medical Associates-Pontiac
Pontiac, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
Henry Ford Rochester Hospital
Rochester Hills, Michigan, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, United States
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, United States
Advanced Breast Care Center PLLC
Warren, Michigan, United States
Henry Ford Health Warren Hospital
Warren, Michigan, United States
Henry Ford Madison Heights Hospital - Breast
Warren, Michigan, United States
Henry Ford Warren Hospital - GLCMS
Warren, Michigan, United States
Macomb Hematology Oncology PC
Warren, Michigan, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, United States
Huron Gastroenterology PC
Ypsilanti, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States
Cox Cancer Center Branson
Branson, Missouri, United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 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
Parkland Health Center - Farmington
Farmington, Missouri, United States
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, United States
Freeman Health System
Joplin, Missouri, United States
Mercy Hospital Joplin
Joplin, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Mercy Infusion Center - Chippewa
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Siteman Cancer Center-South County
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, United States
Mercy Hospital Washington
Washington, Missouri, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Carson Tahoe Regional Medical Center
Carson City, Nevada, United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, United States
Las Vegas Urology - Green Valley
Henderson, Nevada, United States
Las Vegas Urology - Pebble
Henderson, Nevada, United States
Oncology Las Vegas - Henderson
Henderson, Nevada, United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, United States
Las Vegas Urology - Pecos
Las Vegas, Nevada, United States
Desert West Surgery
Las Vegas, Nevada, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, United States
Urology Specialists of Nevada - Central
Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, United States
Las Vegas Prostate Cancer Center
Las Vegas, Nevada, United States
Las Vegas Urology - Sunset
Las Vegas, Nevada, United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, United States
Ann M Wierman MD LTD
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, United States
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, United States
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, United States
Oncology Las Vegas - Tenaya
Las Vegas, Nevada, United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States
University Cancer Center
Las Vegas, Nevada, United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, United States
Renown Regional Medical Center
Reno, Nevada, United States
Saint Mary's Regional Medical Center
Reno, Nevada, United States
Radiation Oncology Associates
Reno, Nevada, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
NYP/Weill Cornell Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
Saint Charles Health System
Bend, Oregon, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, United States
Bay Area Hospital
Coos Bay, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Saint Charles Health System-Redmond
Redmond, Oregon, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, United States
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, United States
Overlake Medical Center
Bellevue, Washington, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Providence Regional Cancer System-Lacey
Lacey, Washington, United States
PeaceHealth Saint John Medical Center
Longview, Washington, United States
Valley Medical Center
Renton, Washington, United States
Pacific Gynecology Specialists
Seattle, Washington, United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, United States
Providence Regional Cancer System-Shelton
Shelton, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States
Providence Regional Cancer System-Yelm
Yelm, Washington, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
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Wieduwilt MJ, Yin J, Kour O, Teske R, Stock W, Escherich C, Yang J, Li Z, Byrd K, Doucette K, Mangan J, Hall S, Mims AS, Jamieson K, Dinner SN, Bseiso AW, Giordano G, Saygin C, Uy GL, Litzow MR, Stone RM. Inotuzumab Ozogamicin Then Blinatumomab for Older Adults With Newly Diagnosed B-Cell ALL: Alliance Study A041703 Cohort 1 Results. J Clin Oncol. 2025 Nov 10;43(32):3526-3535. doi: 10.1200/JCO-25-00307. Epub 2025 Sep 30.
Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.
Other Identifiers
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NCI-2018-02484
Identifier Type: REGISTRY
Identifier Source: secondary_id
A041703
Identifier Type: OTHER
Identifier Source: secondary_id
A041703
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2018-02484
Identifier Type: -
Identifier Source: org_study_id
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