Blood Cancer

EA9181



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

STATUS: Active


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.
  • ELIGIBILITY CRITERIA FOR PREREGISTRATION (TO STEP 0) - INCLUSION

  • 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-ALL or is suspected to have 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 American College of Radiology Imaging Network (ECOG-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, given 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

  • Patients who started any kind of TKI prior to study registration to Step 1 are allowed to proceed on the study if they received no more than 14 days of TKI

  • ELIGIBILITY CRITERIA FOR REGISTRATION TO STEP 1 - INCLUSION

  • 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

  • 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

  • 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 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

  • 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

  • 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. An ECHO/MUGA is required.

  • 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- INCLUSION

  • 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 mLg/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

  • 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) - INCLUSION

  • 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

  • PREREGISTRATION (STEP 0) ELIGIBILITY CRITERIA - EXCLUSION

  • 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 hydroxyurea 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 CML are not eligible

  • STEP 1 REGISTRATION ELIGIBILITY CRITERIA - EXCLUSION

  • 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

  • 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

  • STEP 2: RANDOMIZATION - ELIGIBILITY CRITERIA - EXCLUSION

  • 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

Israel
Jerusalem
Shaare Zedek Medical Center
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United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
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Alaska Oncology and Hematology LLC
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Alaska Women's Cancer Care
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Anchorage Associates in Radiation Medicine
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Anchorage Oncology Centre
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Anchorage Radiation Therapy Center
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Katmai Oncology Group
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Providence Alaska Medical Center
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AL
Birmingham
University of Alabama at Birmingham Cancer Center
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AR
Ft. Smith
Mercy Hospital Fort Smith
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CA
Burbank
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Clovis
Community Cancer Institute
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University Oncology Associates
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Duarte
City of Hope Comprehensive Cancer Center
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La Jolla
UC San Diego Moores Cancer Center
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Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
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Email: ucstudy@uci.edu

CT
New Haven
Yale University
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Email: canceranswers@yale.edu

GA
Augusta
Augusta University Medical Center
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HI
Aiea
Hawaii Cancer Care - Westridge
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Pali Momi Medical Center
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Queen's Cancer Center - Pearlridge
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The Cancer Center of Hawaii-Pali Momi
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Honolulu
Hawaii Cancer Care Inc - Waterfront Plaza
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Hawaii Cancer Care Inc-Liliha
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Kapiolani Medical Center for Women and Children
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Queen's Cancer Cenrer - POB I
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Queen's Cancer Center - Kuakini
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Queen's Medical Center
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Straub Clinic and Hospital
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The Cancer Center of Hawaii-Liliha
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University of Hawaii Cancer Center
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Lihue
Wilcox Memorial Hospital and Kauai Medical Clinic
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IA
Ames
Mary Greeley Medical Center
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McFarland Clinic - Ames
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Boone
McFarland Clinic - Boone
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Fort Dodge
McFarland Clinic - Trinity Cancer Center
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Jefferson
McFarland Clinic - Jefferson
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Marshalltown
McFarland Clinic - Marshalltown
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ID
Boise
Saint Luke's Cancer Institute - Boise
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Email: eslinget@slhs.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
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Meridian
Saint Luke's Cancer Institute - Meridian
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Nampa
Saint Luke's Cancer Institute - Nampa
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Twin Falls
Saint Luke's Cancer Institute - Twin Falls
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IL
Alton
Saint Anthony's Health
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Burr Ridge
Loyola Center for Health at Burr Ridge
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Chicago
Northwestern University
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Evanston
NorthShore University HealthSystem-Evanston Hospital
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Glenview
NorthShore University HealthSystem-Glenbrook Hospital
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Highland Park
NorthShore University HealthSystem-Highland Park Hospital
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Homer Glen
Loyola Medicine Homer Glen
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Lake Forest
Northwestern Medicine Lake Forest Hospital
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Maywood
Loyola University Medical Center
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Melrose Park
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
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Mount Vernon
Good Samaritan Regional Health Center
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KS
Garden City
Central Care Cancer Center - Garden City
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Great Bend
Central Care Cancer Center - Great Bend
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Kansas City
University of Kansas Cancer Center
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Overland Park
University of Kansas Hospital-Indian Creek Campus
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Westwood
University of Kansas Hospital-Westwood Cancer Center
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KY
Louisville
The James Graham Brown Cancer Center at University of Louisville
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LA
Shreveport
LSU Health Sciences Center at Shreveport
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MD
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
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Bethesda
Walter Reed National Military Medical Center
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MI
Ann Arbor
Saint Joseph Mercy Hospital
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Brighton
Saint Joseph Mercy Brighton
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Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Brownstown
Henry Ford Cancer Institute-Downriver
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Email: CTOResearch@hfhs.org

Canton
Saint Joseph Mercy Canton
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Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
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Chelsea
Saint Joseph Mercy Chelsea
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Clinton Township
Henry Ford Macomb Hospital-Clinton Township
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Dearborn
Henry Ford Medical Center-Fairlane
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Detroit
Henry Ford Hospital
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Wayne State University/Karmanos Cancer Institute
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Farmington Hills
Weisberg Cancer Treatment Center
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Flint
Genesee Cancer and Blood Disease Treatment Center
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Genesee Hematology Oncology PC
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Genesys Hurley Cancer Institute
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Hurley Medical Center
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Jackson
Allegiance Health
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Livonia
Trinity Health Saint Mary Mercy Livonia Hospital
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Novi
Henry Ford Medical Center-Columbus
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Shelby Township
Henry Ford Macomb Health Center - Shelby Township
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West Bloomfield
Henry Ford West Bloomfield Hospital
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Ypsilanti
Huron Gastroenterology PC
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Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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MN
Rochester
Mayo Clinic in Rochester
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MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
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Bolivar
Central Care Cancer Center - Bolivar
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Creve Coeur
Siteman Cancer Center at West County Hospital
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Email: info@siteman.wustl.edu

Joplin
Freeman Health System
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Mercy Hospital Joplin
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Kansas City
Research Medical Center
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Rolla
Delbert Day Cancer Institute at PCRMC
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Mercy Clinic-Rolla-Cancer and Hematology
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Saint Joseph
Heartland Regional Medical Center
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Saint Louis
Mercy Hospital Saint Louis
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Mercy Hospital South
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Saint Louis Cancer and Breast Institute-South City
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Siteman Cancer Center at Christian Hospital
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Siteman Cancer Center-South County
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Washington University School of Medicine
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Saint Peters
Siteman Cancer Center at Saint Peters Hospital
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Springfield
CoxHealth South Hospital
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Mercy Hospital Springfield
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Washington
Mercy Hospital Washington
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MS
Southhaven
Baptist Memorial Hospital and Cancer Center-Desoto
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Email: BCCclintrials@bmhcc.org

MT
Missoula
Saint Patrick Hospital - Community Hospital
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Email: amy.hanneman@providence.org

NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
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Email: cancerclinicaltrials@med.unc.edu

Durham
Duke University Medical Center
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Winston-Salem
Wake Forest University Health Sciences
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NJ
New Brunswick
Rutgers Cancer Institute of New Jersey
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NM
Albuquerque
University of New Mexico Cancer Center
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Email: HSC-ClinicalTrialInfo@salud.unm.edu

NY
Bronx
Montefiore Medical Center - Moses Campus
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Email: eskwak@montefiore.org

Rochester
University of Rochester
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OH
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
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Email: cancer@uchealth.com

Cleveland
MetroHealth Medical Center
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Email: ababal@metrohealth.org

Columbus
Ohio State University Comprehensive Cancer Center
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Email: Jamesline@osumc.edu

West Chester
University of Cincinnati Cancer Center-West Chester
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Email: cancer@uchealth.com

OK
Oklahoma City
Mercy Hospital Oklahoma City
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University of Oklahoma Health Sciences Center
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Email: ou-clinical-trials@ouhsc.edu

OR
Bend
Saint Charles Health System
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Email: nosall@stcharleshealthcare.org

Clackamas
Clackamas Radiation Oncology Center
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Email: CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
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Email: CanRsrchStudies@providence.org

Coos Bay
Bay Area Hospital
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Email: cherie.cox@bayareahospital.org

Newberg
Providence Newberg Medical Center
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Email: CanRsrchStudies@providence.org

Oregon City
Providence Willamette Falls Medical Center
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Email: CanRsrchStudies@providence.org

Portland
Providence Portland Medical Center
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Providence Saint Vincent Medical Center
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Redmond
Saint Charles Health System-Redmond
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PA
Allentown
Lehigh Valley Hospital-Cedar Crest
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Email: Morgan_M.Horton@lvhn.org

Bethlehem
Lehigh Valley Hospital - Muhlenberg
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Danville
Geisinger Medical Center
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Email: HemonCCTrials@geisinger.edu

East Stroudsburg
Pocono Medical Center
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Philadelphia
Thomas Jefferson University Hospital
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Email: ONCTrialNow@jefferson.edu

University of Pennsylvania/Abramson Cancer Center
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Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
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Wilkes-Barre
Geisinger Wyoming Valley/Henry Cancer Center
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PR
San Juan
San Juan City Hospital
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SC
Boiling Springs
Prisma Health Cancer Institute - Spartanburg
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Charleston
Medical University of South Carolina
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Email: hcc-clinical-trials@musc.edu

Easley
Prisma Health Cancer Institute - Easley
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Email: Kim.Williams3@prismahealth.org

Greenville
Prisma Health Cancer Institute - Butternut
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Prisma Health Cancer Institute - Eastside
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Prisma Health Cancer Institute - Faris
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Prisma Health Greenville Memorial Hospital
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Greer
Prisma Health Cancer Institute - Greer
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Seneca
Prisma Health Cancer Institute - Seneca
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TN
Franklin
Vanderbilt-Ingram Cancer Center Cool Springs
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Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
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Nashville
Vanderbilt Breast Center at One Hundred Oaks
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Vanderbilt University/Ingram Cancer Center
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TX
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
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Email: canceranswerline@UTSouthwestern.edu

Houston
Houston Methodist Hospital
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UT
Salt Lake City
Huntsman Cancer Institute/University of Utah
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VA
Richmond
Virginia Commonwealth University/Massey Cancer Center
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Email: CTOclinops@vcu.edu

VT
Burlington
University of Vermont Medical Center
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Email: rpo@uvm.edu

WI
Eau Claire
Marshfield Medical Center-EC Cancer Center
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Email: oncology.clinical.trials@marshfieldresearch.org

La Crosse
Gundersen Lutheran Medical Center
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Email: cancerctr@gundersenhealth.org

Madison
University of Wisconsin Carbone Cancer Center
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Marshfield
Marshfield Medical Center-Marshfield
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Email: oncology.clinical.trials@marshfieldresearch.org

Milwaukee
Medical College of Wisconsin
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Minocqua
Marshfield Clinic-Minocqua Center
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Email: oncology.clinical.trials@marshfieldresearch.org

Rice Lake
Marshfield Medical Center-Rice Lake
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Email: oncology.clinical.trials@marshfieldresearch.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
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Email: oncology.clinical.trials@marshfieldresearch.org

Weston
Marshfield Medical Center - Weston
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Email: oncology.clinical.trials@marshfieldresearch.org

PRIMARY OBJECTIVE:
I. To compare the overall survival (OS) following induction with steroids + TKI + blinatumomab versus induction with steroids + TKI + chemotherapy.

SECONDARY OBJECTIVES:
I. To compare the rate of minimal residual disease (MRD) negativity for patients treated with chemotherapy versus (vs) blinatumomab at the end of first induction (week 15).
II. To evaluate the rate of the MRD negativity by treatment arm for those patients MRD positive after the first induction and administered of second induction.
III. To compare event free survival (EFS) for patients initially randomized for chemotherapy vs blinatumomab.
IV. To assess the toxicities of blinatumomab + TKI vs. TKI + chemotherapy in this patient population.
V. To assess the toxicities of the chemotherapy regimen in this patient population.
VI. To describe the outcome of patients who proceed to allogeneic stem cell transplant after treatment with blinatumomab + TKI only.

OUTLINE:

ARM A (PRE-INDUCTION): Patients receive prednisone orally (PO) once daily (QD) on days 1-21 and ponatinib hydrochloride (ponatinib) PO QD or dasatinib PO QD on days 1-21 based on investigator's choice.

Patients are randomized to 1 of 2 arms (Arm B or C). Patients undergo bone marrow aspiration with biopsy, lumbar punctures, echocardiogram (ECHO), and multigated acquisition (MUGA) scans as indicated by investigator.

ARM B (INDUCTION THERAPY): 

CYCLE 1: Patients receive cyclophosphamide intravenously (IV) twice daily (BID) on days 1-3, dexamethasone PO or IV on days 1-4 and 11-14, cytarabine intrathecally (IT) on day 1, doxorubicin hydrochloride (doxorubicin) IV on day 4, vincristine sulfate (vincristine) IV on days 4 and 11, and methotrexate IT on day 8. Patients also receive Mesna 600mg/m^2 IV as a ‘chemoprotectant’ via continuous infusion on days 1-3, (beginning 1 hour prior to cyclophosphamide and completed by 12 hours after the last dose of cyclophosphamide). 

CYCLE 2 (AGE 18-70): Starting in cycle 2, fit patients aged 18-70 receive dasatinib 70mg/day PO or ponatinib 30mg/day PO on days 1-21, methotrexate IV over 24 hours and IT on day 1, and cytarabine IV over 2 hours on days 2-3 of each cycle. On day 22 of cycle 2 or later, as soon as the absolute neutrophil count (ANC) is greater than 1000 cells/ul and platelets are greater than 50,000 cells/ul, patients receive hyper cyclophosphamide, vincristine, doxorubicin, and dexamethasone (CVAD) for 2 additional cycles.

CYCLE 2 (AGE > 70 or unfit < 70): Starting in cycle 2, patients age > 70 or younger unfit patients for Hyper-CVAD receive ponatinib PO QD or dasatinib PO QD on days 1-21 of each cycle. Patients also receive methotrexate IV over 24 hours and IT on day 1, and cytarabine IV over 2 hours on days 2-3 of each cycle. Cycle 1 and 2 regimens are each repeated once starting on day 22 of cycle 2, or later, but as soon as the ANC is greater than 1000 cells/ul and platelets are greater than 50,000 cells/ul.

Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve remission (significant reduction in the amount of leukemia in bone marrow and blood/MRD negative) after 4 cycles may receive alternative treatment, either consolidation with two cycles of Hyper-CVAD followed by TKI maintenance therapy or undergo allogeneic stem cell transplantation followed by maintenance therapy. Patients who do not achieve a remission (MRD positive) are assigned to Arm D. Patients who experience un-resolving renal failure or life-threatening infection which may require a treatment delay of 21 days cross-over to Arm C to receive the prescribed course of blinatumomab. 

ARM C (INDUCTION THERAPY):

CYCLE 1: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28, followed by methotrexate IT on day 28 or 29.

CYCLE 2: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28.

Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

ARM D (RE-INDUCTION): Patients treated on Arm B who remain MRD positive at the end of induction therapy receive blinatumomab based re-induction identical to the regimen described for Arm C.

ARM E (RE-INDUCTION): Patients treated on Arm C who remain MRD positive at the end of induction therapy receive chemotherapy based re-induction which is identical to regimen described for Arm B according to patient's age and the pre-specified chemotherapy arm.

Patients whose molecular test remains MRD positive after re-induction proceed to follow-up at the discretion of the investigator or receive anti CD-19 CAR- T cell therapy, inotuzumab ozogamicin, intensive chemotherapy, or palliative care.

Patients are followed up for 10 years from the date of registration.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


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