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Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
Sponsor: National Cancer Institute (NCI)
Summary
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.
Official title: A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor (TKI) Induction With Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL) in Adults
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
348
Start Date
2021-01-25
Completion Date
2028-07-01
Last Updated
2026-10-26
Healthy Volunteers
No
Interventions
Biospecimen Collection
Correlative studies
Blinatumomab
Given IV
Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy
Cyclophosphamide
Given IV
Cytarabine
Given IV or IT
Dasatinib
Given PO
Dexamethasone
Given PO or IV
Doxorubicin Hydrochloride
Given IV
Echocardiography Test
Undergo ECHO
Electrocardiography
Undergo ECG
Lumbar Puncture
Undergo lumbar puncture
Mesna
Given IV
Methotrexate
Given IV or IT
Multigated Acquisition Scan
Undergo MUGA
Ponatinib Hydrochloride
Given PO
Prednisone
Given PO
Vincristine Sulfate
Given IV
Locations (211)
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
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 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
Yale University
New Haven, Connecticut, United States
Augusta University Medical Center
Augusta, Georgia, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, United States
Kuakini Medical Center
Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, United States
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 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
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, United States
Northwestern University
Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, 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
Northwestern Medicine Lake Forest Hospital
Lake Forest, 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
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Mary Greeley Medical Center
Ames, Iowa, United States
McFarland Clinic - Ames
Ames, Iowa, United States
McFarland Clinic - Boone
Boone, Iowa, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, United States
McFarland Clinic - Marshalltown
Marshalltown, 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-Indian Creek Campus
Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
University of Michigan Rogel Cancer Center
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
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States
Trinity Health Medical Center - Canton
Canton, 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 Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, 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
Allegiance Health
Jackson, 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 Medical Center-Columbus
Novi, Michigan, United States
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, United States
Trinity Health IHA Medical Group-Alice Gustafson Center
Pontiac, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, United States
Henry Ford Macomb Health Center - Shelby Township
Shelby, Michigan, United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States