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Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

StatusRecruiting
PhasePhase 3
Started2017-09-20
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 71 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-01
Study Status, Contacts/Locations v70
Study sitesdetails revised at 8 of 460 sites
2026-08-04
Study Status, Contacts/Locations v69
Study sites460 entries, revised
UniversityUPMC of PittsburghHillman Cancer Institute (UPCI)Center
2026-07-01
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v68
Primary endpoint(s) modified1 entry, revised
WasEFS
NowEvent-free survival (EFS)
Enrollment target310→303
Eligibility criteria+922 characters
[...] e eligible. Patients with Burkitt type ALL are NOT eligible PatientsREGISTRATION whoELIGIBILITY have BCR-ABL fusion transcript determined by fluorescence in situ hybridizationCRITERIA (FISHSTEP 1) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: flow cytometry is to be performed at the local reference lab and must include assessment of CD20 and CD22 positivity, as well as CD29 and CD22 anti-positivity No prior therapy except for limited [...] [...]
Secondary endpoints7 entries, revised
Disease-free survival (DFS) Overall Survival (OS) Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events version 45.0
Study description+6,285 characters
[...] f CALGB 10403, without censoring for transplant. (Phase III) III. To determine the safety and tolerability of a reduced dose of inotuzumab ozogamicin and two cycles of blinatumomab added to the pediatric-inspired regimen of CALGB 10403 (Pilor cohort). SECONDARY OBJECTIVES: I. To determine the impact of inotuzum [...] zogamicin to the pediatric-inspired regimen of CALGB 10403. TERTIARYCORRELATIVE SCIENCE OBJECTIVES: I. To assess both the correlation of MRD post-i [...] atures including initial white blood cell (WBC), ethnicity, gendersex and age at diagnosis. III. To evaluate the impact of inotuz [...] impact of ad [...]
Study sitesdetails revised at 29 of 460 sites
2026-06-01
Study Status, Contacts/Locations v67
Study sitesdetails revised at 3 of 460 sites
2026-05-07
Study Status, Contacts/Locations v66
Study sites461→460
Show 45 earlier versions
2026-04-23
Suspended→Recruiting Study Status, Contacts/Locations v65
Trial statusSuspended→Recruiting
Reason stoppedUnacceptable Toxicity→not stated
Study sites460→461
2026-04-06
Study Status, Contacts/Locations v64
Study sites459→460
2026-02-27
Study Status v63
Primary completion date2026-03-31→2027-03-01
Completion date2026-08→2027-08
2026-02-03
Study Status, Contacts/Locations v62
Study sites457→459
2025-09-04
Study Status, Contacts/Locations v61
Study sites458→457
2025-06-24
Study Status, Contacts/Locations v60
Study sites459→458
2025-03-28
Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing v59
Study sites459 entries, revised
SSM Health Good Samaritan Regional UI Health Center Care Mission Cancer and Blood - Des Moines Clinic Phelps Health Delbert Day Cancer Institute Arthur atJ PCRMC TomE BakerChild Comprehensive Cancer Centre
Study titlerevised
Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults withWith Newly Diagnosed B Acute Lymphoblastic Leukemia
2025-01-13
Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing v58
Primary completion date2025-03→2026-03-31
Completion date2025-08→2026-08
Start date2017-06-01→2017-09-20
Study sitesdetails revised at 1 of 459 sites
Study titlerevised
Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults Withwith Newly Diagnosed B Acute Lymphoblastic Leukemia
2024-12-24
Study Status, Contacts/Locations v57
Study sites459 entries, revised
Kaiser Permanente -Sacramento SacramentoMedical Center SCL Health Saint Joseph Hospital - Cancer Centers of Colorado OSF Saint Anthony's Health Great Lakes Cancer Management Specialists-Doctors Park Genesee Cancer and Blood Disease Treatment Center GreatHenry LakesFord River District Hospital Cancer ManagementHematology SpecialistsCenters - Flint Henry Ford Saint John Hospital - Van Elslander Ascension CancerBorgess CenterHospital BorgessHenry Ford Saint John Hospital - Macomb Medical Henry Ford Rochester Hospital Henry Ford Health Warren Hospital Henry Ford Warren Hospital - GLCMS Logan Healt [...] [...]
2024-10-24
Study Status, Contacts/Locations v56
Study sites459 entries, revised
Good Samaritan MedicalHospital Center- Cancer Centers of Colorado SCLIntermountain Health Lutheran MedicalHospital Henry Center AscensionFord Health Saint John Hospital Henry Ford Saint John Hospital - Academic Henry HematologyFord OncologySaint SpecialistsJohn Hospital - Breast MichiganHenry Ford Warren Hospital - Breast SpecialistsMacomb MyMichigan Medical Center Saginaw MyMichigan Medical Center Tawas Henry Ford Madison Heights Hospital -Grosse Pointe Woods Michigan Breast Specialists-Macomb Township Ascension Saint Mary's Hospital Ascension Saint Joseph Hospital Michigan Breast Specialists [...]
2024-08-01
Study Status, Contacts/Locations v55
Study sites459 entries, revised
Kootenai Clinic Cancer ClinicServices - Sandpoint SaintChelsea Joseph Mercy ChelseaHospital Saint Alphonsus MedicalCancer Care Center-Baker City Saint Alphonsus MedicalCancer Care Center-Ontario
2024-05-22
Study Status, Contacts/Locations v54
Study sites459 entries, revised
Banner North Colorado Medical Center Banner McKee Medical Center MedicalMission OncologyCancer and HematologyBlood Associates- Des Moines Trinity Health Saint Joseph Mercy Hospital Ann Arbor SaintTrinity JosephHealth MercyMedical Center - Brighton SaintTrinity JosephHealth MercyMedical Center - Canton Corewell Health Grand Rapids Hospitals - Butterworth Hospital Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Michigan atHealthcare SpectrumProfessionals HealthPontiac SpectrumTrinity Health at Butterworth Campus 21st Century Oncology-Pontiac Saint Joseph Mercy Oakland Ho [...] [...]
2024-04-17
Study Status, Contacts/Locations v53
Primary completion date2024-03→2025-03
Completion date2024-08→2025-08
Study sites459 entries, revised
University of Michigan Health - Sparrow HospitalLansing
2024-02-19
Study Status, Contacts/Locations v52
Study sites459 entries, revised
Corewell Health Lakeland HospitalHospitals - Niles Hospital SpectrumCorewell Health Reed City Hospital Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Upstate Cancer Center at OneidaVerona
2023-08-30
Study Status, Contacts/Locations v51
Study sites459 entries, revised
Hawaii Cancer Care - SavioWestridge MetroUniversity of Michigan Health Hospital- West
2023-04-03
Study Status v50
Primary completion date2023-03→2024-03
2023-03-16
Study Status, Contacts/Locations v49
Study sites459 entries, revised
Saint Alphonsus MedicalCancer Care Center-Nampa Trinity Health IHA Medical Group Hematology Oncology Consultants- Brighton Trinity Health IHA Medical Group Hematology Oncology Consultants- Canton Trinity Health IHA Medical Group Hematology Oncology Consultants- Chelsea Hospital MercyTrinity Health Grand Rapids Hospital Trinity Health Saint Mary's Saint Mary Mercy Livonia Hospital MercyTrinity Health MercyMuskegon CampusHospital Trinity Health IHA Medical Group Hematology Oncology Consultants-Ann Arbor Campus DixieSaint Medical CenterGeorge Regional CancerMedical Center University of Wisconsin [...]
2022-05-24
Recruiting→Suspended Study Status, Contacts/Locations v48
Trial statusRecruiting→Suspended
Reason stoppednot stated→Unacceptable Toxicity
Study sitesdetails revised at 459 of 459 sites
2022-04-18
Study Status, Contacts/Locations v47
Study sitesdetails revised at 2 of 459 sites
2022-03-22
Study Status, Contacts/Locations v46
Study sites456→459
2022-02-16
Study Status, Contacts/Locations v45
Study sites455→456
2022-01-11
Study Status, Contacts/Locations v44
Study sitescontacts updated at 34 of 455 sites
2021-12-13
Study Status, Contacts/Locations v43
Study sitesdetails revised at 30 of 455 sites
2021-11-11
Study Status, Contacts/Locations v42
Study sites454→455
2021-10-11
Study Status, Contacts/Locations v41
Study sites453→454
2021-08-16
Study Status, Contacts/Locations v40
Study sites448→453
2021-07-19
Study Status, Contacts/Locations v39
Study sites443→448
2021-06-09
Study Status, Contacts/Locations v38
Study sites433→443
2021-04-16
Study Status, Contacts/Locations v37
Study sites431→433
2021-03-05
Study Status, Contacts/Locations v36
Study sites430→431
2021-02-05
Study Status, Contacts/Locations v35
Study sites425→430
2021-01-08
Study Status, Contacts/Locations v34
Study sites325→425
2020-12-08
Study Status, Contacts/Locations v33
Study sites307→325
2020-11-10
Study Status, Contacts/Locations v32
Study sites304→307
2020-09-03
Study Status, Contacts/Locations v31
Study sites304 entries, revised
Saint Luke's Mountain States TumorCancer Institute - Fruitland Saint Luke's Mountain States TumorCancer Institute - Meridian Saint Luke's Mountain States TumorCancer Institute - Nampa Saint Luke's Mountain States TumorCancer Institute - Twin Falls Overlake Hospital Medical Center
2020-07-22
Study Status, Contacts/Locations v30
Study sites299→304
2020-06-03
Study Status, Contacts/Locations v29
Study sites297→299
2020-05-06
Study Status, Contacts/Locations v28
Study sites294→297
2020-04-09
Study Status, Contacts/Locations v27
Study sites293→294
2020-03-04
Study Status, Contacts/Locations v26
Study sites255→293
2020-02-04
Study Status, Contacts/Locations v25
Study sites246→255
2020-01-07
Study Status, Contacts/Locations v24
Study sites244→246
2019-11-19
Study Status, Contacts/Locations v23
Study sites241→244
2019-10-21
Study Status, Contacts/Locations v22
Study sites238→241
2019-09-18
Study Status, Contacts/Locations v21
Study sites238 entries, revised
Ascension Via Christi RegionalHospitals Medical CenterWichita Froedtert and the Medical College of Wisconsin
This phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. 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 ozogamicin to kill them. Chemotherapy drugs, such as \[intervention\], 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 work better in treating young adults with B acute lymphoblastic leukemia.
Trial Details
NCT Number NCT03150693
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions B Acute Lymphoblastic Leukemia
Enrollment 303 participants
Start Date 2017-09-20
Primary Completion 2027-03-01 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-02