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

April 9, 2024 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

348

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91031
        • Suspended
        • Shaare Zedek Medical Center
  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • Recruiting
        • San Juan City Hospital
        • Principal Investigator:
          • Luis J. Santos Reyes
        • Contact:
          • Site Public Contact
          • Phone Number: 787-763-1296
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham Cancer Center
        • Contact:
        • Principal Investigator:
          • Sravanti Rangaraju
    • Alaska
      • Anchorage, Alaska, United States, 98508
        • Suspended
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, United States, 99504
        • Suspended
        • Anchorage Radiation Therapy Center
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Anchorage Oncology Centre
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Katmai Oncology Group
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Providence Alaska Medical Center
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Suspended
        • Mercy Hospital Fort Smith
    • California
      • Burbank, California, United States, 91505
        • Suspended
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Clovis, California, United States, 93611
        • Recruiting
        • Community Cancer Institute
        • Principal Investigator:
          • Haifaa Abdulhaq
        • Contact:
          • Site Public Contact
          • Phone Number: 559-387-1827
      • Clovis, California, United States, 93611
        • Suspended
        • University Oncology Associates
      • Duarte, California, United States, 91010
        • Suspended
        • City of Hope Comprehensive Cancer Center
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Principal Investigator:
          • James K. Mangan
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Principal Investigator:
          • Deepa Jeyakumar
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Lourdes M. Mendez
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University Medical Center
        • Principal Investigator:
          • Vamsi Kota
        • Contact:
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Recruiting
        • Pali Momi Medical Center
        • Principal Investigator:
          • Craig S. Boddy
        • Contact:
          • Site Public Contact
          • Phone Number: 808-486-6000
      • 'Aiea, Hawaii, United States, 96701
        • Suspended
        • Queen's Cancer Center - Pearlridge
      • 'Aiea, Hawaii, United States, 96701
        • Suspended
        • The Cancer Center of Hawaii-Pali Momi
      • 'Aiea, Hawaii, United States, 96701
        • Recruiting
        • Hawaii Cancer Care - Westridge
        • Principal Investigator:
          • Craig S. Boddy
        • Contact:
      • Honolulu, Hawaii, United States, 96826
        • Recruiting
        • Kapiolani Medical Center for Women and Children
        • Principal Investigator:
          • Craig S. Boddy
        • Contact:
          • Site Public Contact
          • Phone Number: 808-983-6090
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Hawaii Cancer Care Inc - Waterfront Plaza
        • Principal Investigator:
          • Craig S. Boddy
        • Contact:
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Straub Clinic and Hospital
        • Principal Investigator:
          • Craig S. Boddy
        • Contact:
          • Site Public Contact
          • Phone Number: 808-522-4333
      • Honolulu, Hawaii, United States, 96813
        • Suspended
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, United States, 96813
        • Suspended
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96813
        • Suspended
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96817
        • Suspended
        • Hawaii Cancer Care Inc-Liliha
      • Honolulu, Hawaii, United States, 96817
        • Suspended
        • Kuakini Medical Center
      • Honolulu, Hawaii, United States, 96817
        • Suspended
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, United States, 96817
        • Suspended
        • The Cancer Center of Hawaii-Liliha
      • Lihue, Hawaii, United States, 96766
        • Suspended
        • Wilcox Memorial Hospital and Kauai Medical Clinic
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Fruitland, Idaho, United States, 83619
        • Suspended
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Suspended
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, United States, 83686
        • Suspended
        • Saint Luke's Cancer Institute - Nampa
      • Twin Falls, Idaho, United States, 83301
        • Suspended
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton, Illinois, United States, 62002
        • Suspended
        • Saint Anthony's Health
      • Burr Ridge, Illinois, United States, 60527
        • Suspended
        • Loyola Center for Health at Burr Ridge
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Shira N. Dinner
        • Contact:
      • Evanston, Illinois, United States, 60201
        • Active, not recruiting
        • NorthShore University HealthSystem-Evanston Hospital
      • Glenview, Illinois, United States, 60026
        • Active, not recruiting
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Highland Park, Illinois, United States, 60035
        • Active, not recruiting
        • NorthShore University HealthSystem-Highland Park Hospital
      • Homer Glen, Illinois, United States, 60491
        • Suspended
        • Loyola Medicine Homer Glen
      • Lake Forest, Illinois, United States, 60045
        • Active, not recruiting
        • Northwestern Medicine Lake Forest Hospital
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Principal Investigator:
          • Stephanie B. Tsai
        • Contact:
          • Site Public Contact
          • Phone Number: 708-226-4357
      • Melrose Park, Illinois, United States, 60160
        • Suspended
        • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
      • Mount Vernon, Illinois, United States, 62864
        • Suspended
        • Good Samaritan Regional Health Center
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Mary Greeley Medical Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Boone, Iowa, United States, 50036
        • Recruiting
        • McFarland Clinic - Boone
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • McFarland Clinic - Trinity Cancer Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Jefferson, Iowa, United States, 50129
        • Recruiting
        • McFarland Clinic - Jefferson
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Marshalltown, Iowa, United States, 50158
        • Recruiting
        • McFarland Clinic - Marshalltown
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Suspended
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, United States, 67530
        • Suspended
        • Central Care Cancer Center - Great Bend
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Principal Investigator:
          • Kenneth Byrd
        • Contact:
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • University of Kansas Hospital-Indian Creek Campus
        • Principal Investigator:
          • Kenneth Byrd
        • Contact:
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital-Westwood Cancer Center
        • Principal Investigator:
          • Kenneth Byrd
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • The James Graham Brown Cancer Center at University of Louisville
        • Principal Investigator:
          • Mohamed M. Hegazi
        • Contact:
          • Site Public Contact
          • Phone Number: 502-562-3429
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Active, not recruiting
        • LSU Health Sciences Center at Shreveport
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • Principal Investigator:
          • Jonathan A. Webster
        • Contact:
      • Bethesda, Maryland, United States, 20889-5600
        • Recruiting
        • Walter Reed National Military Medical Center
        • Principal Investigator:
          • Alexander Dew
        • Contact:
          • Site Public Contact
          • Phone Number: 301-319-2100
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
      • Brighton, Michigan, United States, 48114
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Justin Shaya
      • Brownstown, Michigan, United States, 48183
        • Suspended
        • Henry Ford Cancer Institute-Downriver
      • Canton, Michigan, United States, 48188
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Justin Shaya
      • Chelsea, Michigan, United States, 48118
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Justin Shaya
      • Clarkston, Michigan, United States, 48346
      • Clarkston, Michigan, United States, 48346
      • Clinton Township, Michigan, United States, 48038
        • Suspended
        • Henry Ford Macomb Hospital-Clinton Township
      • Dearborn, Michigan, United States, 48126
        • Suspended
        • Henry Ford Medical Center-Fairlane
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University/Karmanos Cancer Institute
        • Principal Investigator:
          • Jay Yang
        • Contact:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Haythem Y. Ali
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Weisberg Cancer Treatment Center
        • Principal Investigator:
          • Jay Yang
        • Contact:
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesee Cancer and Blood Disease Treatment Center
        • Contact:
        • Principal Investigator:
          • Justin Shaya
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesee Hematology Oncology PC
        • Contact:
        • Principal Investigator:
          • Justin Shaya
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesys Hurley Cancer Institute
        • Contact:
        • Principal Investigator:
          • Justin Shaya
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Hurley Medical Center
        • Contact:
        • Principal Investigator:
          • Justin Shaya
      • Jackson, Michigan, United States, 49201
        • Suspended
        • Allegiance Health
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Justin Shaya
      • Novi, Michigan, United States, 48377
        • Suspended
        • Henry Ford Medical Center-Columbus
      • Pontiac, Michigan, United States, 48341
      • Shelby, Michigan, United States, 48315
        • Suspended
        • Henry Ford Macomb Health Center - Shelby Township
      • West Bloomfield, Michigan, United States, 48322
        • Suspended
        • Henry Ford West Bloomfield Hospital
      • Ypsilanti, Michigan, United States, 48106
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Justin Shaya
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Antoine Saliba
    • Mississippi
      • Southhaven, Mississippi, United States, 38671
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Desoto
        • Principal Investigator:
          • Salil Goorha
        • Contact:
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Suspended
        • Saint Louis Cancer and Breast Institute-Ballwin
      • Bolivar, Missouri, United States, 65613
        • Suspended
        • Central Care Cancer Center - Bolivar
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Principal Investigator:
          • Geoffrey L. Uy
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Suspended
        • Mercy Hospital Joplin
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Kansas City, Missouri, United States, 64132
        • Recruiting
        • Research Medical Center
        • Principal Investigator:
          • Suman Kambhampati
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Suspended
        • Delbert Day Cancer Institute at PCRMC
      • Rolla, Missouri, United States, 65401
        • Suspended
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Saint Joseph, Missouri, United States, 64506
        • Suspended
        • Heartland Regional Medical Center
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Geoffrey L. Uy
        • Contact:
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • Saint Louis, Missouri, United States, 63109
        • Suspended
        • Saint Louis Cancer and Breast Institute-South City
      • Saint Louis, Missouri, United States, 63128
        • Suspended
        • Mercy Hospital South
      • Saint Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Principal Investigator:
          • Geoffrey L. Uy
        • Contact:
      • Saint Louis, Missouri, United States, 63136
        • Recruiting
        • Siteman Cancer Center at Christian Hospital
        • Principal Investigator:
          • Geoffrey L. Uy
        • Contact:
      • Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Principal Investigator:
          • Geoffrey L. Uy
        • Contact:
      • Springfield, Missouri, United States, 65804
        • Suspended
        • Mercy Hospital Springfield
      • Springfield, Missouri, United States, 65807
        • Suspended
        • CoxHealth South Hospital
      • Washington, Missouri, United States, 63090
        • Suspended
        • Mercy Hospital Washington
    • Montana
      • Missoula, Montana, United States, 59802
        • Suspended
        • Saint Patrick Hospital - Community Hospital
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Principal Investigator:
          • Neil D. Palmisiano
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Charles Foucar
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Campus
        • Principal Investigator:
          • Ioannis Mantzaris
        • Contact:
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Paul M. Barr
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Principal Investigator:
          • Katarzyna J. Jamieson
        • Contact:
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Harry P. Erba
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
        • Principal Investigator:
          • Bayard L. Powell
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
        • Principal Investigator:
          • Emily K. Curran
        • Contact:
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • MetroHealth Medical Center
        • Principal Investigator:
          • William Tse
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Meixiao Long
        • Contact:
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • University of Cincinnati Cancer Center-West Chester
        • Principal Investigator:
          • Emily K. Curran
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Mohamad Khawandanah
      • Oklahoma City, Oklahoma, United States, 73120
        • Suspended
        • Mercy Hospital Oklahoma City
    • Oregon
      • Bend, Oregon, United States, 97701
        • Suspended
        • Saint Charles Health System
      • Clackamas, Oregon, United States, 97015
        • Suspended
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Providence Cancer Institute Clackamas Clinic
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Coos Bay, Oregon, United States, 97420
        • Suspended
        • Bay Area Hospital
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Oregon City, Oregon, United States, 97045
        • Recruiting
        • Providence Willamette Falls Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Redmond, Oregon, United States, 97756
        • Suspended
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital-Cedar Crest
        • Contact:
        • Principal Investigator:
          • Justin Shaya
      • Bethlehem, Pennsylvania, United States, 18017
        • Recruiting
        • Lehigh Valley Hospital - Muhlenberg
        • Contact:
        • Principal Investigator:
          • Justin Shaya
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph J. Vadakara
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Recruiting
        • Pocono Medical Center
        • Contact:
        • Principal Investigator:
          • Justin Shaya
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Principal Investigator:
          • Lindsay Wilde
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania/Abramson Cancer Center
        • Principal Investigator:
          • Keith W. Pratz
        • Contact:
          • Site Public Contact
          • Phone Number: 800-474-9892
      • Pittsburgh, Pennsylvania, United States, 15232
        • Active, not recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Joseph J. Vadakara
    • South Carolina
      • Boiling Springs, South Carolina, United States, 29316
        • Recruiting
        • Prisma Health Cancer Institute - Spartanburg
        • Principal Investigator:
          • Suzanne R. Fanning
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Praneeth Baratam
        • Contact:
      • Easley, South Carolina, United States, 29640
        • Suspended
        • Prisma Health Cancer Institute - Easley
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health Cancer Institute - Eastside
        • Principal Investigator:
          • Suzanne R. Fanning
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
      • Greenville, South Carolina, United States, 29605
        • Suspended
        • Prisma Health Greenville Memorial Hospital
      • Greenville, South Carolina, United States, 29605
        • Suspended
        • Prisma Health Cancer Institute - Butternut
      • Greenville, South Carolina, United States, 29605
        • Suspended
        • Prisma Health Cancer Institute - Faris
      • Greer, South Carolina, United States, 29650
        • Recruiting
        • Prisma Health Cancer Institute - Greer
        • Principal Investigator:
          • Suzanne R. Fanning
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
      • Seneca, South Carolina, United States, 29672
        • Recruiting
        • Prisma Health Cancer Institute - Seneca
        • Principal Investigator:
          • Suzanne R. Fanning
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Suspended
        • Vanderbilt-Ingram Cancer Center Cool Springs
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Memphis
        • Principal Investigator:
          • Salil Goorha
        • Contact:
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Principal Investigator:
          • Sanjay R. Mohan
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
      • Nashville, Tennessee, United States, 37204
        • Suspended
        • Vanderbilt Breast Center at One Hundred Oaks
    • Texas
      • Dallas, Texas, United States, 75390
        • Suspended
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Principal Investigator:
          • Shilpan Shah
        • Contact:
          • Site Public Contact
          • Phone Number: 713-790-2700
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Principal Investigator:
          • Srinivas K. Tantravahi
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-4101
          • Email: rpo@uvm.edu
        • Principal Investigator:
          • Diego A. Adrianzen Herrera
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University/Massey Cancer Center
        • Principal Investigator:
          • Keri R. Maher
        • Contact:
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Suspended
        • Providence Regional Cancer System-Aberdeen
      • Bellingham, Washington, United States, 98225
        • Suspended
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, United States, 98531
        • Suspended
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, United States, 98026
        • Suspended
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, United States, 98201
        • Suspended
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, United States, 98029
        • Suspended
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, United States, 99336
        • Recruiting
        • Kadlec Clinic Hematology and Oncology
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Lacey, Washington, United States, 98503
        • Suspended
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, United States, 98632
        • Suspended
        • PeaceHealth Saint John Medical Center
      • Seattle, Washington, United States, 98104
        • Suspended
        • Pacific Gynecology Specialists
      • Seattle, Washington, United States, 98107
        • Suspended
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, United States, 98122-5711
        • Suspended
        • Swedish Medical Center-Cherry Hill
      • Seattle, Washington, United States, 98122
        • Suspended
        • Swedish Medical Center-First Hill
      • Sedro-Woolley, Washington, United States, 98284
        • Suspended
        • PeaceHealth United General Medical Center
      • Shelton, Washington, United States, 98584
        • Suspended
        • Providence Regional Cancer System-Shelton
      • Vancouver, Washington, United States, 98664
        • Recruiting
        • PeaceHealth Southwest Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Walla Walla, Washington, United States, 99362
        • Suspended
        • Providence Saint Mary Regional Cancer Center
      • Yelm, Washington, United States, 98597
        • Suspended
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54701
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • Kurt Oettel
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Principal Investigator:
          • Ryan J. Mattison
        • Contact:
      • Marshfield, Wisconsin, United States, 54449
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Ehab L. Atallah
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
      • Minocqua, Wisconsin, United States, 54548
      • Rice Lake, Wisconsin, United States, 54868
      • Stevens Point, Wisconsin, United States, 54482
      • Weston, Wisconsin, United States, 54476

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ELIGIBILITY CRITERIA FOR PREREGISTRATION (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-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
  • 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
  • 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
  • Patient must not have unstable epilepsy that requires treatment
  • Patients with lymphoid blast crisis 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
  • 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.

  • 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 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
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A (steroid, TKI), Single Arm Pre-Induction
Patients receive prednisone PO QD on days 1-21 and ponatinib PO QD or dasatinib PO QD on days 1-21 based on investigator's choice.
Procedure: Lumbar Puncture
Undergo lumbar puncture
Other Names:
  • LP
  • Spinal Tap
Drug: Dasatinib
Given PO
Other Names:
  • BMS-354825
  • Dasatinib Hydrate
  • Dasatinib Monohydrate
  • Sprycel
Drug: Prednisone
Given PO
Other Names:
  • Deltasone
  • Orasone
  • .delta.1-Cortisone
  • 1, 2-Dehydrocortisone
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-Cortisone
  • Delta-Dome
  • Deltacortene
  • Deltacortisone
  • Deltadehydrocortisone
  • Deltison
  • Deltra
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednisone
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednisone Intensol
  • Prednisonum
  • Prednitone
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednisone
Drug: Ponatinib Hydrochloride
Given PO
Other Names:
  • AP24534 HCl
  • Iclusig
Procedure: Biospecimen Collection
Correlative studies
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Echocardiography
Undergo ECHO
Other Names:
  • EC
Procedure: Multigated Acquisition Scan
Undergo MUGA
Other Names:
  • Blood Pool Scan
  • Equilibrium Radionuclide Angiography
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuclide Ventriculography
  • RNVG
  • SYMA Scanning
  • Synchronized Multigated Acquisition Scanning
Procedure: Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy
Procedure: Electrocardiography
Undergo ECG
Other Names:
  • ECG
  • EKG
Experimental: Arm B (steroid, TKI, chemotherapy)
See Detailed Description.
Procedure: Lumbar Puncture
Undergo lumbar puncture
Other Names:
  • LP
  • Spinal Tap
Drug: Dasatinib
Given PO
Other Names:
  • BMS-354825
  • Dasatinib Hydrate
  • Dasatinib Monohydrate
  • Sprycel
Drug: Cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamide Monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Oncovin
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • Adriamycin
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
Drug: Dexamethasone
Given PO or IV
Other Names:
  • Decadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasone Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazone
  • ZoDex
Drug: Ponatinib Hydrochloride
Given PO
Other Names:
  • AP24534 HCl
  • Iclusig
Procedure: Biospecimen Collection
Correlative studies
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Echocardiography
Undergo ECHO
Other Names:
  • EC
Procedure: Multigated Acquisition Scan
Undergo MUGA
Other Names:
  • Blood Pool Scan
  • Equilibrium Radionuclide Angiography
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuclide Ventriculography
  • RNVG
  • SYMA Scanning
  • Synchronized Multigated Acquisition Scanning
Procedure: Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy
Procedure: Electrocardiography
Undergo ECG
Other Names:
  • ECG
  • EKG
Drug: Cytarabine
Given IV or IT
Other Names:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-Beta-D-arabinofuranosylcytosine
  • 1.beta.-D-Arabinofuranosylcytosine
  • 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-cell
  • Arabine
  • Arabinofuranosylcytosine
  • Arabinosylcytosine
  • Aracytidine
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine Arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-beta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Drug: Mesna
Given IV
Other Names:
  • Mesnex
  • 2-Mercaptoethanesulfonate, Sodium Salt
  • Ausobronc
  • D-7093
  • Filesna
  • Mercaptoethane Sulfonate
  • Mercaptoethanesulfonate
  • Mesnil
  • Mesnum
  • Mexan
  • Mistabron
  • Mistabronco
  • Mitexan
  • Mucofluid
  • Mucolene
  • UCB 3983
  • Uromitexan
  • Ziken
Drug: Methotrexate
Given IV or IT
Other Names:
  • Abitrexate
  • Folex
  • Mexate
  • MTX
  • Alpha-Methopterin
  • Amethopterin
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertrexate
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Methoblastin
  • Methotrexate LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
Experimental: Arm C (steroid, TKI, chemotherapy, immunotherapy)

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.
Procedure: Lumbar Puncture
Undergo lumbar puncture
Other Names:
  • LP
  • Spinal Tap
Drug: Dasatinib
Given PO
Other Names:
  • BMS-354825
  • Dasatinib Hydrate
  • Dasatinib Monohydrate
  • Sprycel
Drug: Dexamethasone
Given PO or IV
Other Names:
  • Decadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasone Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazone
  • ZoDex
Biological: Blinatumomab
Given IV
Other Names:
  • Blincyto
  • Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody
  • Anti-CD19/Anti-CD3 Recombinant Bispecific Monoclonal Antibody MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • MEDI538
Drug: Ponatinib Hydrochloride
Given PO
Other Names:
  • AP24534 HCl
  • Iclusig
Procedure: Biospecimen Collection
Correlative studies
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Echocardiography
Undergo ECHO
Other Names:
  • EC
Procedure: Multigated Acquisition Scan
Undergo MUGA
Other Names:
  • Blood Pool Scan
  • Equilibrium Radionuclide Angiography
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuclide Ventriculography
  • RNVG
  • SYMA Scanning
  • Synchronized Multigated Acquisition Scanning
Procedure: Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy
Procedure: Electrocardiography
Undergo ECG
Other Names:
  • ECG
  • EKG
Drug: Mesna
Given IV
Other Names:
  • Mesnex
  • 2-Mercaptoethanesulfonate, Sodium Salt
  • Ausobronc
  • D-7093
  • Filesna
  • Mercaptoethane Sulfonate
  • Mercaptoethanesulfonate
  • Mesnil
  • Mesnum
  • Mexan
  • Mistabron
  • Mistabronco
  • Mitexan
  • Mucofluid
  • Mucolene
  • UCB 3983
  • Uromitexan
  • Ziken
Drug: Methotrexate
Given IV or IT
Other Names:
  • Abitrexate
  • Folex
  • Mexate
  • MTX
  • Alpha-Methopterin
  • Amethopterin
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertrexate
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Methoblastin
  • Methotrexate LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
Experimental: Arm D (steroid, TKI, chemotherapy, immunotherapy)

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.

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.
Procedure: Lumbar Puncture
Undergo lumbar puncture
Other Names:
  • LP
  • Spinal Tap
Drug: Dasatinib
Given PO
Other Names:
  • BMS-354825
  • Dasatinib Hydrate
  • Dasatinib Monohydrate
  • Sprycel
Drug: Cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamide Monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
Drug: Dexamethasone
Given PO or IV
Other Names:
  • Decadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasone Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazone
  • ZoDex
Biological: Blinatumomab
Given IV
Other Names:
  • Blincyto
  • Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody
  • Anti-CD19/Anti-CD3 Recombinant Bispecific Monoclonal Antibody MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • MEDI538
Drug: Ponatinib Hydrochloride
Given PO
Other Names:
  • AP24534 HCl
  • Iclusig
Procedure: Biospecimen Collection
Correlative studies
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Echocardiography
Undergo ECHO
Other Names:
  • EC
Procedure: Multigated Acquisition Scan
Undergo MUGA
Other Names:
  • Blood Pool Scan
  • Equilibrium Radionuclide Angiography
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuclide Ventriculography
  • RNVG
  • SYMA Scanning
  • Synchronized Multigated Acquisition Scanning
Procedure: Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy
Procedure: Electrocardiography
Undergo ECG
Other Names:
  • ECG
  • EKG
Drug: Methotrexate
Given IV or IT
Other Names:
  • Abitrexate
  • Folex
  • Mexate
  • MTX
  • Alpha-Methopterin
  • Amethopterin
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertrexate
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Methoblastin
  • Methotrexate LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
Experimental: Arm E (steroid, TKI, chemotherapy)

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.
Procedure: Lumbar Puncture
Undergo lumbar puncture
Other Names:
  • LP
  • Spinal Tap
Drug: Dasatinib
Given PO
Other Names:
  • BMS-354825
  • Dasatinib Hydrate
  • Dasatinib Monohydrate
  • Sprycel
Drug: Cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamide Monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Oncovin
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • Adriamycin
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
Drug: Dexamethasone
Given PO or IV
Other Names:
  • Decadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasone Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazone
  • ZoDex
Drug: Ponatinib Hydrochloride
Given PO
Other Names:
  • AP24534 HCl
  • Iclusig
Procedure: Biospecimen Collection
Correlative studies
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Echocardiography
Undergo ECHO
Other Names:
  • EC
Procedure: Multigated Acquisition Scan
Undergo MUGA
Other Names:
  • Blood Pool Scan
  • Equilibrium Radionuclide Angiography
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuclide Ventriculography
  • RNVG
  • SYMA Scanning
  • Synchronized Multigated Acquisition Scanning
Procedure: Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy
Procedure: Electrocardiography
Undergo ECG
Other Names:
  • ECG
  • EKG
Drug: Cytarabine
Given IV or IT
Other Names:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-Beta-D-arabinofuranosylcytosine
  • 1.beta.-D-Arabinofuranosylcytosine
  • 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-cell
  • Arabine
  • Arabinofuranosylcytosine
  • Arabinosylcytosine
  • Aracytidine
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine Arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-beta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Drug: Methotrexate
Given IV or IT
Other Names:
  • Abitrexate
  • Folex
  • Mexate
  • MTX
  • Alpha-Methopterin
  • Amethopterin
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertrexate
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Methoblastin
  • Methotrexate LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Time between randomization and death from any cause, assessed up to 10 years from the date of registration
Will compare OS following induction with steroids + tyrosine kinase inhibitor (TKI) + blinatumomab and induction with steroids + TKI + chemotherapy. Will be based on an intent-to-treat analysis. Estimates of OS including medians and confidence intervals, will be calculated using the Kaplan-Meier method. Comparisons of OS between treatment arms will be conducted using the one-sided stratified log-rank test with steroid responsiveness, type of TKI intended to receive and age at diagnosis, the same factors used in randomization, as stratification factors. Cox proportional hazards models of OS, stratified on the same factors used in the randomization, will be used to assess the effect of treatment by adjusting other possible clinical and biological risk factors, including cytogenetic abnormalities.
Time between randomization and death from any cause, assessed up to 10 years from the date of registration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of minimal residual disease (MRD) negativity
Time Frame: At week 15
Will be centrally evaluated. Will be compared between two arms using Fisher's exact test with a one-sided type I error rate of 2.5%. Multivariable logistic regression modeling will be used to adjust for other possible clinical and biological risk factors. For patients registered to Step 3 (re-induction), the rates of MRD negativity and their corresponding 95% confidence intervals after re-induction will be given by treatment arm.
At week 15
Event free survival (EFS)
Time Frame: Time from randomization to failure to achieve induction molecular remission by week 15, confirmed molecular relapse after molecular remission or to death in remission, assessed up to 10 years from the date of registration
Will be based on an intent-to-treat analysis. Estimates of EFS including medians and confidence intervals, will be calculated using the Kaplan-Meier method. Comparisons of EFS between treatment arms will be conducted using the one-sided stratified log-rank test with steroid responsiveness, type of TKI intended to receive and age at diagnosis, the same factors used in randomization, as stratification factors. Cox proportional hazards models of EFS, stratified on the same factors used in the randomization, will be used to assess the effect of treatment by adjusting other possible clinical and biological risk factors, including cytogenetic abnormalities
Time from randomization to failure to achieve induction molecular remission by week 15, confirmed molecular relapse after molecular remission or to death in remission, assessed up to 10 years from the date of registration
Rate of MRD negativity
Time Frame: After re-induction and safety
Will be centrally evaluated. Will be compared between two arms using Fisher's exact test with a one-sided type I error rate of 2.5%. Multivariable logistic regression modeling will be used to adjust for other possible clinical and biological risk factors. For patients registered to Step 3 (re-induction), the rates of MRD negativity and their corresponding 95% confidence intervals after re-induction will be given by treatment arm.
After re-induction and safety
Incidence of adverse events
Time Frame: Up to 10 years from the date of registration
All toxicity grades and reportable adverse events will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Up to 10 years from the date of registration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Yishai Ofran, 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 Major Dates

Study Start (Actual)

January 25, 2021

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2020-06381 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180820 (U.S. NIH Grant/Contract)
  • EA9181 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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