RECRUITING

Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults

Conditions

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-01-25

Study Completion:2028-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04530565

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* ELIGIBILITY CRITERIA FOR PRE-REGISTRATION (TO STEP 0) * Patient must be \>= 18 and =\< 75 years of age * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-3 * Patient must be newly diagnosed with B acute lymphoblastic leukemia (B-ALL) or is suspected to have acute lymphoblastic leukemia (ALL) * Patient must have BCR-ABL1 positive disease. The diagnosis of ALL and the presence of BCR-ABL translocation must be confirmed centrally. Patients can be registered and begin step 1 therapy while awaiting central laboratory eligibility confirmation * NOTE: Bone marrow aspirate and/or peripheral blood specimen must be submitted to the ECOG-American College of Radiology Imaging Network (ACRIN) Leukemia Laboratory at MD Anderson Cancer Center to determine patient's eligibility for registration to Step 1 or confirm patient evaluability. Centrally fluorescence-activated cell sorting (FACS) analysis will be performed to determine B-ALL and to exclude acute myeloid leukemia (AML) or acute bi-phenotypic leukemia and baseline BCR-ABL status will be determined by fluorescent in situ hybridization (FISH). The ECOG-ACRIN Leukemia Laboratory will forward results within 48 hours of receipt of the specimen to the submitting institution. Bone marrow aspirate is to be from first pull (initial or re-direct). Specimens must contain sufficient blast cells. In cases where the bone marrow aspiration may be inadequate, or the bone marrow examination has already been performed prior to study consent and enrollment on Step 0, peripheral blood may be submitted, with recommendation that adequate circulating blasts are present (\> 10%). If a diagnosis of BCR-ABL positive B-ALL has already been established by local Clinical Laboratory Improvement Act (CLIA) certified laboratories, the patient may be registered to step 1 without waiting for central confirmation * Patient must not have a diagnosis of BCR/ABL T-ALL * Patient must not have received chemotherapy for B-ALL. Patients who received up to five days of therapy (hydroxyurea and/or steroids of any kind) with the aim to reduce disease burden prior to study registration to Step 1 are eligible * Patient must not have unstable epilepsy that requires treatment * Patients with lymphoid blast crisis chronic myeloid leukemia (CML) are not eligible * ELIGIBILITY CRITERIA FOR REGISTRATION TO STEP 1 * Patient must have a diagnosis of Philadelphia chromosome positive (Ph+) ALL that has been determined locally and bone marrow and/or peripheral blood was sent and receipt confirmed for central confirmation or determined centrally by the ECOG-ACRIN Leukemia Laboratory at MD Anderson Cancer Center * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of step 1 registration, while on study treatment, and until at least six months after the last dose of study treatment * Total bilirubin =\< 3 mg/dL (patients with Gilbert's syndrome must have a total bilirubin =\< 5 mg/dL) (obtained =\< 28 days prior to step 1 registration) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X the institutional upper limit of normal (ULN) (obtained =\< 28 days prior to step 1 registration) * Estimated creatinine clearance \> 45 mL/min (based on Cockcroft-Gault equation) (obtained =\< 28 days prior to step 1 registration) * Patients with acute organ dysfunction at step 1 registration, which may be attributed to leukemia can be registered regardless of lab results at presentation. Such patients will be allowed to register and can start Arm A steroid + TKI therapy but will only be allowed to proceed to step 2 randomization if the eligibility criteria outlined is met * Patients who presented with no evidence of acute organ dysfunction but during step 0 experienced a rise in liver enzymes which investigator suspects to be a side effect of any of prescribed drugs, are allowed to be registered regardless of the level of liver enzymes. Step 2 randomization must be withheld until the eligibility criteria outline is met but no more than 14 days after concluding Arm A therapy * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable or on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load and if indicated, on treatment * Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patient must not have active concomitant malignancy. Patients on chronic hormonal therapy for breast or prostate cancer or patients treated with maintenance with targeted agents but are in remission with no evidence for the primary malignancies are eligible * Patient must not have complaints of symptoms and/or have clinical and/or radiological signs that indicate an uncontrolled infection or any other concurrent medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients must be class 2B or better * Investigators must confirm which TKI patient is to receive * NOTE: Patients with known T315I mutation status should receive ponatinib treatment * NOTE: In situations due to insurance coverage issues and the pre-selected TKI is not immediately available, patients can receive dasatinib or imatinib during step 1. The investigator must re-specify dasatinib or ponatinib prior to step 2 randomization and from then on patients must receive the pre-selected TKI only * ELIGIBILITY CRITERIA FOR RANDOMIZATION TO STEP 2 * Patient must have completed at least 7 and no more than 21 days of protocol-treatment on Arm A prior to step 2 randomization. (Days in which arm A therapy was withheld for any reason are not counted) * NOTE: First day of steroids prescription after registration will be considered as the first day of study therapy. The selected TKI must be initiated prior to randomization * Patients who presented with acute organ dysfunction within 2 weeks of registration to step 1 must have total bilirubin =\< 2 X institutional upper limit of normal (ULN) * AST(SGOT)/ ALT(SGPT) =\< 2 X the institutional upper limit of normal (ULN) * Estimated creatinine clearance \> 45 mL/min (based on Cockcroft-Gault equation) * Investigators must confirm which TKI patient is to receive. * NOTE: Patients with known T315I mutation status should receive ponatinib treatment * For patients under age 70, intended chemotherapy regimen must have been determined prior to randomization * Patient must not have active central nervous system (CNS) involvement by leukemic blasts. Patients with signs of CNS involvement at presentation are eligible for randomization if clearance of blasts from the cerebrospinal fluid (CSF) is demonstrated * Patients must have resolved any serious infectious complications related to therapy * Any significant medical complications related to therapy must have resolved * ELIGIBILITY CRITERIA FOR REGISTRATION TO STEP 3 (RE-INDUCTION) * Institution has received centralized MRD results confirming positive status * Patients who presented with acute organ dysfunction within 2 weeks of registration to step 1 must have total bilirubin =\< 2 X institutional ULN * Patients who presented with acute organ dysfunction must have AST (SGOT)/ALT (SGPT) =\< 2 X institutional upper limit of normal (ULN) * Patients who presented with acute organ dysfunction must have an estimated creatinine clearance \> 45 mL/min (based on Cockcroft-Gault equation) * Investigators must confirm which TKI patient is to receive * NOTE: Patients with known T315I mutation status should receive ponatinib treatment * For patients under age 70 and previously assigned to Arm C, intended chemotherapy regimen must have been determined * Step 3 (Re-Induction): Patients must have resolved any serious infectious complications related to therapy * Step 3 (Re-Induction): Any significant medical complications related to therapy must have resolved	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* ELIGIBILITY CRITERIA FOR PRE-REGISTRATION (TO STEP 0)
* Patient must be \>= 18 and =\< 75 years of age
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-3
* Patient must be newly diagnosed with B acute lymphoblastic leukemia (B-ALL) or is suspected to have acute lymphoblastic leukemia (ALL)
* Patient must have BCR-ABL1 positive disease. The diagnosis of ALL and the presence of BCR-ABL translocation must be confirmed centrally. Patients can be registered and begin step 1 therapy while awaiting central laboratory eligibility confirmation
* NOTE: Bone marrow aspirate and/or peripheral blood specimen must be submitted to the ECOG-American College of Radiology Imaging Network (ACRIN) Leukemia Laboratory at MD Anderson Cancer Center to determine patient's eligibility for registration to Step 1 or confirm patient evaluability. Centrally fluorescence-activated cell sorting (FACS) analysis will be performed to determine B-ALL and to exclude acute myeloid leukemia (AML) or acute bi-phenotypic leukemia and baseline BCR-ABL status will be determined by fluorescent in situ hybridization (FISH). The ECOG-ACRIN Leukemia Laboratory will forward results within 48 hours of receipt of the specimen to the submitting institution. Bone marrow aspirate is to be from first pull (initial or re-direct). Specimens must contain sufficient blast cells. In cases where the bone marrow aspiration may be inadequate, or the bone marrow examination has already been performed prior to study consent and enrollment on Step 0, peripheral blood may be submitted, with recommendation that adequate circulating blasts are present (\> 10%). If a diagnosis of BCR-ABL positive B-ALL has already been established by local Clinical Laboratory Improvement Act (CLIA) certified laboratories, the patient may be registered to step 1 without waiting for central confirmation
* Patient must not have a diagnosis of BCR/ABL T-ALL
* Patient must not have received chemotherapy for B-ALL. Patients who received up to five days of therapy (hydroxyurea and/or steroids of any kind) with the aim to reduce disease burden prior to study registration to Step 1 are eligible
* Patient must not have unstable epilepsy that requires treatment
* Patients with lymphoid blast crisis chronic myeloid leukemia (CML) are not eligible
* ELIGIBILITY CRITERIA FOR REGISTRATION TO STEP 1
* Patient must have a diagnosis of Philadelphia chromosome positive (Ph+) ALL that has been determined locally and bone marrow and/or peripheral blood was sent and receipt confirmed for central confirmation or determined centrally by the ECOG-ACRIN Leukemia Laboratory at MD Anderson Cancer Center
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of step 1 registration, while on study treatment, and until at least six months after the last dose of study treatment
* Total bilirubin =\< 3 mg/dL (patients with Gilbert's syndrome must have a total bilirubin =\< 5 mg/dL) (obtained =\< 28 days prior to step 1 registration)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X the institutional upper limit of normal (ULN) (obtained =\< 28 days prior to step 1 registration)
* Estimated creatinine clearance \> 45 mL/min (based on Cockcroft-Gault equation) (obtained =\< 28 days prior to step 1 registration)
* Patients with acute organ dysfunction at step 1 registration, which may be attributed to leukemia can be registered regardless of lab results at presentation. Such patients will be allowed to register and can start Arm A steroid + TKI therapy but will only be allowed to proceed to step 2 randomization if the eligibility criteria outlined is met
* Patients who presented with no evidence of acute organ dysfunction but during step 0 experienced a rise in liver enzymes which investigator suspects to be a side effect of any of prescribed drugs, are allowed to be registered regardless of the level of liver enzymes. Step 2 randomization must be withheld until the eligibility criteria outline is met but no more than 14 days after concluding Arm A therapy
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable or on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load and if indicated, on treatment
* Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patient must not have active concomitant malignancy. Patients on chronic hormonal therapy for breast or prostate cancer or patients treated with maintenance with targeted agents but are in remission with no evidence for the primary malignancies are eligible
* Patient must not have complaints of symptoms and/or have clinical and/or radiological signs that indicate an uncontrolled infection or any other concurrent medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients must be class 2B or better
* Investigators must confirm which TKI patient is to receive
* NOTE: Patients with known T315I mutation status should receive ponatinib treatment
* NOTE: In situations due to insurance coverage issues and the pre-selected TKI is not immediately available, patients can receive dasatinib or imatinib during step 1. The investigator must re-specify dasatinib or ponatinib prior to step 2 randomization and from then on patients must receive the pre-selected TKI only
* ELIGIBILITY CRITERIA FOR RANDOMIZATION TO STEP 2
* Patient must have completed at least 7 and no more than 21 days of protocol-treatment on Arm A prior to step 2 randomization. (Days in which arm A therapy was withheld for any reason are not counted)
* NOTE: First day of steroids prescription after registration will be considered as the first day of study therapy. The selected TKI must be initiated prior to randomization
* Patients who presented with acute organ dysfunction within 2 weeks of registration to step 1 must have total bilirubin =\< 2 X institutional upper limit of normal (ULN)
* AST(SGOT)/ ALT(SGPT) =\< 2 X the institutional upper limit of normal (ULN)
* Estimated creatinine clearance \> 45 mL/min (based on Cockcroft-Gault equation)
* Investigators must confirm which TKI patient is to receive.
* NOTE: Patients with known T315I mutation status should receive ponatinib treatment
* For patients under age 70, intended chemotherapy regimen must have been determined prior to randomization
* Patient must not have active central nervous system (CNS) involvement by leukemic blasts. Patients with signs of CNS involvement at presentation are eligible for randomization if clearance of blasts from the cerebrospinal fluid (CSF) is demonstrated
* Patients must have resolved any serious infectious complications related to therapy
* Any significant medical complications related to therapy must have resolved
* ELIGIBILITY CRITERIA FOR REGISTRATION TO STEP 3 (RE-INDUCTION)
* Institution has received centralized MRD results confirming positive status
* Patients who presented with acute organ dysfunction within 2 weeks of registration to step 1 must have total bilirubin =\< 2 X institutional ULN
* Patients who presented with acute organ dysfunction must have AST (SGOT)/ALT (SGPT) =\< 2 X institutional upper limit of normal (ULN)
* Patients who presented with acute organ dysfunction must have an estimated creatinine clearance \> 45 mL/min (based on Cockcroft-Gault equation)
* Investigators must confirm which TKI patient is to receive
* NOTE: Patients with known T315I mutation status should receive ponatinib treatment
* For patients under age 70 and previously assigned to Arm C, intended chemotherapy regimen must have been determined
* Step 3 (Re-Induction): Patients must have resolved any serious infectious complications related to therapy
* Step 3 (Re-Induction): Any significant medical complications related to therapy must have resolved

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Yishai Ofran

PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233

United States

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508

United States

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504

United States

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, 99508

United States

Alaska Oncology and Hematology LLC

Anchorage, Alaska, 99508

United States

Alaska Women's Cancer Care

Anchorage, Alaska, 99508

United States

Anchorage Oncology Centre

Anchorage, Alaska, 99508

United States

Katmai Oncology Group

Anchorage, Alaska, 99508

United States

Providence Alaska Medical Center

Anchorage, Alaska, 99508

United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903

United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505

United States

Community Cancer Institute

Clovis, California, 93611

United States

University Oncology Associates

Clovis, California, 93611

United States

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612

United States

UC San Diego Moores Cancer Center

La Jolla, California, 92093

United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868

United States

Yale University

New Haven, Connecticut, 06520

United States

Augusta University Medical Center

Augusta, Georgia, 30912

United States

Hawaii Cancer Care - Westridge

'Aiea, Hawaii, 96701

United States

Pali Momi Medical Center

'Aiea, Hawaii, 96701

United States

Queen's Cancer Center - Pearlridge

'Aiea, Hawaii, 96701

United States

The Cancer Center of Hawaii-Pali Momi

'Aiea, Hawaii, 96701

United States

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813

United States

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813

United States

Queen's Medical Center

Honolulu, Hawaii, 96813

United States

Straub Clinic and Hospital

Honolulu, Hawaii, 96813

United States

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813

United States

Hawaii Cancer Care Inc-Liliha

Honolulu, Hawaii, 96817

United States

Kuakini Medical Center

Honolulu, Hawaii, 96817

United States

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817

United States

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, 96817

United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826

United States

Wilcox Memorial Hospital and Kauai Medical Clinic

Lihue, Hawaii, 96766

United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619

United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642

United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687

United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301

United States

OSF Saint Anthony's Health Center

Alton, Illinois, 62002

United States

Loyola Center for Health at Burr Ridge

Burr Ridge, Illinois, 60527

United States

Northwestern University

Chicago, Illinois, 60611

United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201

United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, 60026

United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, 60035

United States

Loyola Medicine Homer Glen

Homer Glen, Illinois, 60491

United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045

United States

Loyola University Medical Center

Maywood, Illinois, 60153

United States

Marjorie Weinberg Cancer Center at Loyola-Gottlieb

Melrose Park, Illinois, 60160

United States

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864

United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202

United States

Mary Greeley Medical Center

Ames, Iowa, 50010

United States

McFarland Clinic - Ames

Ames, Iowa, 50010

United States

McFarland Clinic - Boone

Boone, Iowa, 50036

United States

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, 50501

United States

McFarland Clinic - Jefferson

Jefferson, Iowa, 50129

United States

McFarland Clinic - Marshalltown

Marshalltown, Iowa, 50158

United States

Central Care Cancer Center - Garden City

Garden City, Kansas, 67846

United States

Central Care Cancer Center - Great Bend

Great Bend, Kansas, 67530

United States

University of Kansas Cancer Center

Kansas City, Kansas, 66160

United States

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, 66211

United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205

United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202

United States

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, 71103

United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

United States

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114

United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114

United States

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183

United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

United States

Trinity Health Medical Center - Canton

Canton, Michigan, 48188

United States

Chelsea Hospital

Chelsea, Michigan, 48118

United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118

United States

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, 48346

United States

Newland Medical Associates-Clarkston

Clarkston, Michigan, 48346

United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038

United States

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, 48126

United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Henry Ford Hospital

Detroit, Michigan, 48202

United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334

United States

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, 48503

United States

Genesee Hematology Oncology PC

Flint, Michigan, 48503

United States

Genesys Hurley Cancer Institute

Flint, Michigan, 48503

United States

Hurley Medical Center

Flint, Michigan, 48503

United States

Allegiance Health

Jackson, Michigan, 49201

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

United States

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044

United States

Henry Ford Medical Center-Columbus

Novi, Michigan, 48377

United States

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, 48341

United States

Newland Medical Associates-Pontiac

Pontiac, Michigan, 48341

United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341

United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601

United States

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604

United States

Henry Ford Macomb Health Center - Shelby Township

Shelby, Michigan, 48315

United States

MyMichigan Medical Center Tawas

Tawas City, Michigan, 48764

United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322

United States

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, 48661

United States

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106

United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671

United States

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, 63011

United States

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

United States

Freeman Health System

Joplin, Missouri, 64804

United States

Mercy Hospital Joplin

Joplin, Missouri, 64804

United States

Research Medical Center

Kansas City, Missouri, 64132

United States

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401

United States

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401

United States

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506

United States

Saint Louis Cancer and Breast Institute-South City

Saint Louis, Missouri, 63109

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Mercy Hospital South

Saint Louis, Missouri, 63128

United States

Siteman Cancer Center-South County

Saint Louis, Missouri, 63129

United States

Siteman Cancer Center at Christian Hospital

Saint Louis, Missouri, 63136

United States

Mercy Hospital Saint Louis

Saint Louis, Missouri, 63141

United States

Siteman Cancer Center at Saint Peters Hospital

Saint Peters, Missouri, 63376

United States

Mercy Hospital Springfield

Springfield, Missouri, 65804

United States

CoxHealth South Hospital

Springfield, Missouri, 65807

United States

Mercy Hospital Washington

Washington, Missouri, 63090

United States

Saint Patrick Hospital - Community Hospital

Missoula, Montana, 59802

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106

United States

Montefiore Medical Center - Moses Campus

Bronx, New York, 10467

United States

University of Rochester

Rochester, New York, 14642

United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219

United States

Case Western Reserve University

Cleveland, Ohio, 44106

United States

MetroHealth Medical Center

Cleveland, Ohio, 44109

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120

United States

Saint Charles Health System

Bend, Oregon, 97701

United States

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015

United States

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, 97015

United States

Bay Area Hospital

Coos Bay, Oregon, 97420

United States

Providence Newberg Medical Center

Newberg, Oregon, 97132

United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon, 97225

United States

Saint Charles Health System-Redmond

Redmond, Oregon, 97756

United States

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103

United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017

United States

Geisinger Medical Center

Danville, Pennsylvania, 17822

United States

Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301

United States

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, 18201

United States

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711

United States

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640

United States

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605

United States

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605

United States

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605

United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615

United States

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650

United States

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672

United States

Vanderbilt-Ingram Cancer Center Cool Springs

Franklin, Tennessee, 37067

United States

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120

United States

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, 37204

United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112

United States

University of Vermont Medical Center

Burlington, Vermont, 05401

United States

University of Vermont and State Agricultural College

Burlington, Vermont, 05405

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington, 98520

United States

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225

United States

Providence Regional Cancer System-Centralia

Centralia, Washington, 98531

United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026

United States

Providence Regional Cancer Partnership

Everett, Washington, 98201

United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029

United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336

United States

Providence Regional Cancer System-Lacey

Lacey, Washington, 98503

United States

PeaceHealth Saint John Medical Center

Longview, Washington, 98632

United States

Pacific Gynecology Specialists

Seattle, Washington, 98104

United States

Swedish Medical Center-Ballard Campus

Seattle, Washington, 98107

United States

Swedish Medical Center-Cherry Hill

Seattle, Washington, 98122-5711

United States

Swedish Medical Center-First Hill

Seattle, Washington, 98122

United States

PeaceHealth United General Medical Center

Sedro-Woolley, Washington, 98284

United States

Providence Regional Cancer System-Shelton

Shelton, Washington, 98584

United States

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664

United States

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, 99362

United States

Providence Regional Cancer System-Yelm

Yelm, Washington, 98597

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601

United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548

United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482

United States

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Yishai Ofran, PRINCIPAL_INVESTIGATOR, ECOG-ACRIN Cancer Research Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-25

Study Completion Date2028-07-01

Study Record Updates

Study Start Date2021-01-25

Study Completion Date2028-07-01

Terms related to this study

Additional Relevant MeSH Terms

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1