Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT03739814
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This phase II trial studies how well inotuzumab ozogamicin and blinatumomab with or without ponatinib work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back after a period of improvement (recurrent), or does not respond to treatment (refractory). 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. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody 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). Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving inotuzumab ozogamicin and blinatumomab with or without ponatinib may be effective in treating patients with newly diagnosed, recurrent or refractory CD22 positive B-lineage acute lymphoblastic leukemia.
Interventions
-
Biospecimen Collection
(Procedure)
Undergo blood sample and cerebrospinal fluid collection
-
Blinatumomab
(Biological)
Given IV
-
Bone Marrow Aspiration
(Procedure)
Undergo bone marrow aspiration
-
Bone Marrow Biopsy
(Procedure)
Undergo bone marrow biopsy
-
Inotuzumab Ozogamicin
(Biological)
Given IV
-
Lumbar Puncture
(Procedure)
Undergo lumbar puncture
-
Ponatinib
(Drug)
Given PO
Eligibility criteria
Conditions
Locations
- 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
- Jupiter Medical Center — Jupiter, 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 Alphonsus Cancer Care Center-Nampa — Nampa, 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
- NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
- Illinois CancerCare-Galesburg — Galesburg, Illinois, United States
- Western Illinois Cancer Treatment Center — Galesburg, Illinois, United States
- NorthShore University HealthSystem-Glenbrook Hospital — Glenview, Illinois, United States
- NorthShore University HealthSystem-Highland Park Hospital — Highland Park, 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
- UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic — Clive, Iowa, United States
- UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States
- UI Health Care Mission Cancer and Blood - Laurel Clinic — Des Moines, Iowa, United States
- UI Health Care Mission Cancer and Blood - Waukee Clinic — Waukee, Iowa, 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
- 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
- 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
- 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
- OptumCare Cancer Care at Fort Apache — 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
- Stony Brook University Medical Center — Stony Brook, 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
- Froedtert Menomonee Falls Hospital — Menomonee Falls, Wisconsin, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- Marshfield Medical Center - Minocqua — Minocqua, Wisconsin, United States
- Froedtert and MCW Moorland Reserve Health Center — New Berlin, Wisconsin, United States
- Drexel Town Square Health Center — Oak Creek, 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
- Froedtert West Bend Hospital/Kraemer Cancer Center — West Bend, Wisconsin, United States
- Marshfield Medical Center - Weston — Weston, Wisconsin, United States
- Centro Comprensivo de Cancer de UPR — San Juan, Puerto Rico
- San Juan City Hospital — San Juan, Puerto Rico
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