Clinical Trial - NCT03007147

       

Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Recruiting

Sponsor: Children's Oncology Group

Collaborators: National Cancer Institute (NCI), EsPhALL network I-BFM Study Group

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03007147

Protocol Info

Short Description: Phase III in Ph+ ALL with Imatinib + Chemotherapy
Long Description: International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones
MGH Status: Open
Sponsor: Coop/COG
Disease Program: Pediatrics

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.
Condition Title Intervention Phase
Acute Lymphoblastic Leukemia B Acute Lymphoblastic Leukemia Mixed Phenotype Acute Leukemia T Acute Lymphoblastic Leukemia Allogeneic Hematopoietic Stem Cell Transplantation Cyclophosphamide Cytarabine Daunorubicin Hydrochloride Dexamethasone Dexrazoxane Hydrochloride Doxorubicin Etoposide Filgrastim Ifosfamide Imatinib Mesylate Laboratory Biomarker Analysis Leucovorin Calcium Mercaptopurine Mercaptopurine Methotrexate Methylprednisolone Pegaspargase Prednisolone Questionnaire Administration Therapeutic Hydrocortisone Thioguanine Vincristine Sulfate Phase 3
Study Type Interventional
Official Title International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones

Primary Outcome Measures

Disease free survival (DFS) [Time Frame: From randomization to first event (relapse, second malignancy, or death in complete remission) or time to last follow-up for patients without events, assessed up to 3 years] [Designated as safety issue: ]


Secondary Outcome Measures

Imatinib mesylate administration after allogeneic hematopoietic stem cell transplantation (HSCT) in high risk Ph+ ALL patients [Time Frame: Up to 2 years] [Designated as safety issue: ]

Event free survival (EFS) of high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate [Time Frame: From the date of bone marrow for minimal residual disease (MRD) assessment at end-IB to first event or time to last follow-up for patients without events, assessed up to 3 years] [Designated as safety issue: ]

Incidence of grade 3 or higher infections in standard risk Ph+ ALL patients in the two randomized arms [Time Frame: Up to 3 years] [Designated as safety issue: ]

EFS of all enrolled patients [Time Frame: From enrollment until the first occurrence of: M3 marrow at the end of Induction IA, relapse, second malignancy, or death as a first event, assessed up to 3 years] [Designated as safety issue: ]

Overall survival (OS) of all enrolled patients [Time Frame: From study enrollment to death from any cause, assessed up to 3 years] [Designated as safety issue: ]

OS of standard risk patients [Time Frame: From randomization to death from any cause, assessed up to 3 years] [Designated as safety issue: ]

OS of high risk patients [Time Frame: From the date of MRD assessment at end-IB to death from any cause, assessed up to 3 years] [Designated as safety issue: ]

Estimated Enrollment: 700
Study Start Date: July 2017
Estimated Study Completion Date: June 2028
Estimated Primary Completion Date: June 2028
Arms Assigned Interventions

Experimental:Arm A (imatinib mesylate, EsPhALL chemotherapy)

See Detailed Description
Drug:Vincristine Sulfate
Given IV

Experimental:Arm B (imatinib mesylate, COG/BFM chemotherapy)

See Detailed Description.

Experimental:Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)

See Detailed Description
Procedure:Allogeneic Hematopoietic Stem Cell Transplantation
Undergo HSCT

Eligibility

Ages Eligible for Study: 21 Years-21 Years

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • • For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled
  • • For patients who have not previously enrolled on APEC14B1 prior to enrollment on AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if marrow sample unavailable) must be available to develop an MRD probe
  • • In addition, laboratory reports detailing evidence of BCR-ABL1 fusion must be submitted for rapid central review within 72 hours of study enrollment
  • • Newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO] definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR
  • • Patient must have previously started induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy
  • • Patient has not received more than 14 days of multiagent induction therapy beginning with the first dose of vinCRIStine
  • • Patient may have started imatinib prior to study entry but has not received more than 14 days of imatinib
  • • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2
  • • Direct bilirubin =< 2.0 mg/dL
  • • Shortening fraction of >= 27% by echocardiogram
  • • Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram
  • • Corrected QT interval, QTc < 480 msec
  • • Note: Repeat echocardiogram is not required if echocardiogram was obtained within 21 days of study enrollment
  • • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2
  • • Serum creatinine within normal limits based on age/gender, as follows:
  • • 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
  • • 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
  • • 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)
  • • 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
  • • 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
  • • >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)

Exclusion Criteria:

  • • Known history of chronic myelogenous leukemia (CML)
  • • ALL developing after a previous cancer treated with cytotoxic chemotherapy
  • • Active, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
  • • Down syndrome
  • • Pregnancy and breast feeding
  • • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential
  • • Lactating females who plan to breastfeed their infants
  • • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
  • • Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block
  • • Prior treatment with dasatinib, or any BCR-ABL1 inhibitor other than imatinib
  • • All patients and/or their parents or legal guardians must sign a written informed consent
  • • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03007147

Locations

  • United States, Alabama
    • Children's Hospital of Alabama Birmingham, Alabama, United States, 35233
  • United States, Alaska
    • Providence Alaska Medical Center Anchorage, Alaska, United States, 99508
  • United States, Arizona
    • Banner Children's at Desert Mesa, Arizona, United States, 85202
    • Phoenix Childrens Hospital Phoenix, Arizona, United States, 85016
  • United States, Arkansas
    • Arkansas Children's Hospital Little Rock, Arkansas, United States, 72202-3591
  • United States, California
    • Kaiser Permanente Downey Medical Center Downey, California, United States, 90242
    • City of Hope Comprehensive Cancer Center Duarte, California, United States, 91010
    • Loma Linda University Medical Center Loma Linda, California, United States, 92354
    • Miller Children's and Women's Hospital Long Beach Long Beach, California, United States, 90806
    • Children's Hospital Los Angeles Los Angeles, California, United States, 90027
    • Cedars Sinai Medical Center Los Angeles, California, United States, 90048
    • Valley Children's Hospital Madera, California, United States, 93636
    • Children's Hospital and Research Center at Oakland Oakland, California, United States, 94609-1809
    • Kaiser Permanente-Oakland Oakland, California, United States, 94611
    • Children's Hospital of Orange County Orange, California, United States, 92868
    • Lucile Packard Children's Hospital Stanford University Palo Alto, California, United States, 94304
    • University of California Davis Comprehensive Cancer Center Sacramento, California, United States, 95817
    • Rady Children's Hospital - San Diego San Diego, California, United States, 92123
    • UCSF Medical Center-Mission Bay San Francisco, California, United States, 94158
  • United States, Colorado
    • Children's Hospital Colorado Aurora, Colorado, United States, 80045
    • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado, United States, 80218
  • United States, Connecticut
    • Connecticut Children's Medical Center Hartford, Connecticut, United States, 06106
  • United States, Delaware
    • Alfred I duPont Hospital for Children Wilmington, Delaware, United States, 19803
  • United States, District of Columbia
    • MedStar Georgetown University Hospital Washington, District of Columbia, United States, 20007
    • Children's National Medical Center Washington, District of Columbia, United States, 20010
  • United States, Florida
    • Broward Health Medical Center Fort Lauderdale, Florida, United States, 33316
    • Golisano Children's Hospital of Southwest Florida Fort Myers, Florida, United States, 33908
    • University of Florida Health Science Center - Gainesville Gainesville, Florida, United States, 32610
    • Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida, United States, 33021
    • Nemours Children's Clinic-Jacksonville Jacksonville, Florida, United States, 32207
    • Palms West Radiation Therapy Loxahatchee Groves, Florida, United States, 33470
    • University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida, United States, 33136
    • Nicklaus Children's Hospital Miami, Florida, United States, 33155
    • Miami Cancer Institute Miami, Florida, United States, 33176
    • AdventHealth Orlando Orlando, Florida, United States, 32803
    • Arnold Palmer Hospital for Children Orlando, Florida, United States, 32806
    • Nemours Children's Hospital Orlando, Florida, United States, 32827
    • Sacred Heart Hospital Pensacola, Florida, United States, 32504
    • Johns Hopkins All Children's Hospital Saint Petersburg, Florida, United States, 33701
    • Tampa General Hospital Tampa, Florida, United States, 33606
    • Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida, United States, 33607
    • Saint Mary's Hospital West Palm Beach, Florida, United States, 33407
  • United States, Georgia
    • Children's Healthcare of Atlanta - Egleston Atlanta, Georgia, United States, 30322
    • Medical Center of Central Georgia Macon, Georgia, United States, 31201
    • Memorial Health University Medical Center Savannah, Georgia, United States, 31404
  • United States, Hawaii
    • Kapiolani Medical Center for Women and Children Honolulu, Hawaii, United States, 96826
  • United States, Idaho
    • Saint Luke's Cancer Institute - Boise Boise, Idaho, United States, 83712
  • United States, Illinois
    • Lurie Children's Hospital-Chicago Chicago, Illinois, United States, 60611
    • University of Illinois Chicago, Illinois, United States, 60612
    • Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois, United States, 60453
    • Advocate Children's Hospital-Park Ridge Park Ridge, Illinois, United States, 60068
    • Saint Jude Midwest Affiliate Peoria, Illinois, United States, 61637
  • United States, Indiana
    • Riley Hospital for Children Indianapolis, Indiana, United States, 46202
    • Saint Vincent Hospital and Health Care Center Indianapolis, Indiana, United States, 46260
  • United States, Iowa
    • Blank Children's Hospital Des Moines, Iowa, United States, 50309
    • University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa, United States, 52242
  • United States, Kentucky
    • University of Kentucky/Markey Cancer Center Lexington, Kentucky, United States, 40536
    • Norton Children's Hospital Louisville, Kentucky, United States, 40202
  • United States, Louisiana
    • Ochsner Medical Center Jefferson New Orleans, Louisiana, United States, 70121
  • United States, Maine
    • Eastern Maine Medical Center Bangor, Maine, United States, 04401
    • Maine Children's Cancer Program Scarborough, Maine, United States, 04074
  • United States, Maryland
    • Sinai Hospital of Baltimore Baltimore, Maryland, United States, 21215
    • Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland, United States, 21287
    • Walter Reed National Military Medical Center Bethesda, Maryland, United States, 20889-5600
  • United States, Massachusetts
    • Tufts Children's Hospital Boston, Massachusetts, United States, 02111
    • Massachusetts General Hospital Cancer Center Boston, Massachusetts, United States, 02114
    • Dana-Farber Cancer Institute Boston, Massachusetts, United States, 02215
  • United States, Michigan
    • C S Mott Children's Hospital Ann Arbor, Michigan, United States, 48109
    • Ascension Saint John Hospital Detroit, Michigan, United States, 48236
    • Michigan State University Clinical Center East Lansing, Michigan, United States, 48824-7016
    • Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan, United States, 49503
    • Bronson Methodist Hospital Kalamazoo, Michigan, United States, 49007
    • Beaumont Children's Hospital-Royal Oak Royal Oak, Michigan, United States, 48073
  • United States, Minnesota
    • Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota, United States, 55404
    • University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota, United States, 55455
    • Mayo Clinic in Rochester Rochester, Minnesota, United States, 55905
  • United States, Mississippi
    • University of Mississippi Medical Center Jackson, Mississippi, United States, 39216
  • United States, Missouri
    • Children's Mercy Hospitals and Clinics Kansas City, Missouri, United States, 64108
    • Washington University School of Medicine Saint Louis, Missouri, United States, 63110
    • Mercy Hospital Saint Louis Saint Louis, Missouri, United States, 63141
  • United States, Nebraska
    • Children's Hospital and Medical Center of Omaha Omaha, Nebraska, United States, 68114
    • University of Nebraska Medical Center Omaha, Nebraska, United States, 68198
  • United States, Nevada
    • University Medical Center of Southern Nevada Las Vegas, Nevada, United States, 89102
    • Sunrise Hospital and Medical Center Las Vegas, Nevada, United States, 89109
    • Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada, United States, 89135
    • Summerlin Hospital Medical Center Las Vegas, Nevada, United States, 89144
  • United States, New Hampshire
    • Dartmouth Hitchcock Medical Center Lebanon, New Hampshire, United States, 03756
  • United States, New Jersey
    • Hackensack University Medical Center Hackensack, New Jersey, United States, 07601
    • Morristown Medical Center Morristown, New Jersey, United States, 07960
    • Saint Peter's University Hospital New Brunswick, New Jersey, United States, 08901
    • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey, United States, 08903
    • Saint Joseph's Regional Medical Center Paterson, New Jersey, United States, 07503
  • United States, New Mexico
    • University of New Mexico Cancer Center Albuquerque, New Mexico, United States, 87102
  • United States, New York
    • Albany Medical Center Albany, New York, United States, 12208
    • Montefiore Medical Center - Moses Campus Bronx, New York, United States, 10467
    • Maimonides Medical Center Brooklyn, New York, United States, 11219
    • Roswell Park Cancer Institute Buffalo, New York, United States, 14263
    • The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York, United States, 11040
    • Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York, United States, 10016
    • Mount Sinai Hospital New York, New York, United States, 10029
    • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York, United States, 10032
    • Memorial Sloan Kettering Cancer Center New York, New York, United States, 10065
    • University of Rochester Rochester, New York, United States, 14642
    • Stony Brook University Medical Center Stony Brook, New York, United States, 11794
    • State University of New York Upstate Medical University Syracuse, New York, United States, 13210
  • United States, North Carolina
    • Mission Hospital Asheville, North Carolina, United States, 28801
    • UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina, United States, 27599
    • Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina, United States, 28203
    • Novant Health Presbyterian Medical Center Charlotte, North Carolina, United States, 28204
    • Duke University Medical Center Durham, North Carolina, United States, 27710
    • East Carolina University Greenville, North Carolina, United States, 27834
    • Wake Forest University Health Sciences Winston-Salem, North Carolina, United States, 27157
  • United States, North Dakota
    • Sanford Broadway Medical Center Fargo, North Dakota, United States, 58122
  • United States, Ohio
    • Children's Hospital Medical Center of Akron Akron, Ohio, United States, 44308
    • Cincinnati Children's Hospital Medical Center Cincinnati, Ohio, United States, 45229
    • Rainbow Babies and Childrens Hospital Cleveland, Ohio, United States, 44106
    • Cleveland Clinic Foundation Cleveland, Ohio, United States, 44195
    • Nationwide Children's Hospital Columbus, Ohio, United States, 43205
    • Dayton Children's Hospital Dayton, Ohio, United States, 45404
    • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio, United States, 43606
  • United States, Oklahoma
    • University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma, United States, 73104
  • United States, Oregon
    • Oregon Health and Science University Portland, Oregon, United States, 97239
  • United States, Pennsylvania
    • Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania, United States, 18103
    • Geisinger Medical Center Danville, Pennsylvania, United States, 17822
    • Penn State Children's Hospital Hershey, Pennsylvania, United States, 17033
    • Children's Hospital of Philadelphia Philadelphia, Pennsylvania, United States, 19104
    • Saint Christopher's Hospital for Children Philadelphia, Pennsylvania, United States, 19134
    • Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania, United States, 15224
  • United States, South Carolina
    • Medical University of South Carolina Charleston, South Carolina, United States, 29425
    • Prisma Health Richland Hospital Columbia, South Carolina, United States, 29203
    • BI-LO Charities Children's Cancer Center Greenville, South Carolina, United States, 29605
  • United States, South Dakota
    • Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota, United States, 57117-5134
  • United States, Tennessee
    • T C Thompson Children's Hospital Chattanooga, Tennessee, United States, 37403
    • East Tennessee Childrens Hospital Knoxville, Tennessee, United States, 37916
    • The Children's Hospital at TriStar Centennial Nashville, Tennessee, United States, 37203
    • Vanderbilt University/Ingram Cancer Center Nashville, Tennessee, United States, 37232
  • United States, Texas
    • Texas Tech University Health Sciences Center-Amarillo Amarillo, Texas, United States, 79106
    • Dell Children's Medical Center of Central Texas Austin, Texas, United States, 78723
    • Driscoll Children's Hospital Corpus Christi, Texas, United States, 78411
    • Medical City Dallas Hospital Dallas, Texas, United States, 75230
    • UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas, United States, 75390
    • El Paso Children's Hospital El Paso, Texas, United States, 79905
    • Cook Children's Medical Center Fort Worth, Texas, United States, 76104
    • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas, United States, 77030
    • M D Anderson Cancer Center Houston, Texas, United States, 77030
    • Covenant Children's Hospital Lubbock, Texas, United States, 79410
    • Children's Hospital of San Antonio San Antonio, Texas, United States, 78207
    • Methodist Children's Hospital of South Texas San Antonio, Texas, United States, 78229
    • University of Texas Health Science Center at San Antonio San Antonio, Texas, United States, 78229
  • United States, Utah
    • Primary Children's Hospital Salt Lake City, Utah, United States, 84113
  • United States, Vermont
    • University of Vermont and State Agricultural College Burlington, Vermont, United States, 05405
  • United States, Virginia
    • University of Virginia Cancer Center Charlottesville, Virginia, United States, 22908
    • Inova Fairfax Hospital Falls Church, Virginia, United States, 22042
    • Children's Hospital of The King's Daughters Norfolk, Virginia, United States, 23507
    • Naval Medical Center - Portsmouth Portsmouth, Virginia, United States, 23708-2197
    • Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia, United States, 23298
    • Carilion Children's Roanoke, Virginia, United States, 24014
  • United States, Washington
    • Seattle Children's Hospital Seattle, Washington, United States, 98105
    • Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington, United States, 99204
    • Mary Bridge Children's Hospital and Health Center Tacoma, Washington, United States, 98405
    • Madigan Army Medical Center Tacoma, Washington, United States, 98431
  • United States, West Virginia
    • West Virginia University Healthcare Morgantown, West Virginia, United States, 26506
  • United States, Wisconsin
    • Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin, United States, 54301
    • University of Wisconsin Hospital and Clinics Madison, Wisconsin, United States, 53792
    • Marshfield Medical Center-Marshfield Marshfield, Wisconsin, United States, 54449
    • Children's Hospital of Wisconsin Milwaukee, Wisconsin, United States, 53226
  • Australia, New South Wales
    • John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales, Australia, 2310
    • Sydney Children's Hospital Randwick, New South Wales, Australia, 2031
    • The Children's Hospital at Westmead Westmead, New South Wales, Australia, 2145
  • Australia, Queensland
    • Queensland Children's Hospital South Brisbane, Queensland, Australia, 4101
  • Australia, Western Australia
    • Princess Margaret Hospital for Children Perth, Western Australia, Australia, 6008
    • Perth Children's Hospital Perth, Western Australia, Australia, 6009
  • Austria,
    • St. Anna Children's Hospital Vienna, , Austria, 1090
  • Belgium, Flemish Brabant
    • Hospitals Leuven Leuven, Flemish Brabant, Belgium, 3000
  • Canada, Alberta
    • Alberta Children's Hospital Calgary, Alberta, Canada, T3B 6A8
    • University of Alberta Hospital Edmonton, Alberta, Canada, T6G 2B7
  • Canada, Manitoba
    • CancerCare Manitoba Winnipeg, Manitoba, Canada, R3E 0V9
  • Canada, Nova Scotia
    • IWK Health Centre Halifax, Nova Scotia, Canada, B3K 6R8
  • Canada, Ontario
    • McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario, Canada, L8N 3Z5
    • Kingston Health Sciences Centre Kingston, Ontario, Canada, K7L 2V7
    • Children's Hospital London, Ontario, Canada, N6A 5W9
    • Children's Hospital of Eastern Ontario Ottawa, Ontario, Canada, K1H 8L1
    • Hospital for Sick Children Toronto, Ontario, Canada, M5G 1X8
  • Canada, Quebec
    • The Montreal Children's Hospital of the MUHC Montreal, Quebec, Canada, H3H 1P3
    • Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec, Canada, H3T 1C5
  • Canada, Saskatchewan
    • Saskatoon Cancer Centre Saskatoon, Saskatchewan, Canada, S7N 4H4
  • Canada,
    • Centre Hospitalier Universitaire de Quebec Quebec, , Canada, G1V 4G2
  • Chile,
    • Hospital Roberto del Rio-Universidad de Chile Santiago, , Chile,
  • Czechia,
    • University Hospital Motol Praha, , Czechia, 15018, 5-Motol
  • Finland,
    • Tampere University Hospital Tampere, , Finland, 33521
  • France,
    • CHU Hopital Sud Rennes, , France, 35203
  • Germany, Schleswig-Holstein
    • University Medical Center chleswig- Campus Kiel Kiel,, Schleswig-Holstein, Germany, 24105
  • Germany,
    • Universitätsklinik Eppendorf Hamburg, , Germany, 20246
  • Hong Kong, Kowloon
    • Hong Kong Children's Hospital Kowloon Bay, Kowloon, Hong Kong,
  • Israel, Central District
    • Schneider Children's Medical Center of Israel Petah-Tikva, Central District, Israel, 4920235
  • Italy,
    • Clinica Pediatrica Università Milano-Bicocca Ospedale S. Gerardo/Fondazione MBBM Monza, , Italy, 20900
  • Netherlands,
    • Princess Máxima Center for Pediatric Oncology Utrecht, , Netherlands, 3584 CT
  • New Zealand, Auckland
    • Starship Children's Hospital Grafton, Auckland, New Zealand, 1145
  • New Zealand,
    • Christchurch Hospital Christchurch, , New Zealand, 8011
  • Puerto Rico,
    • HIMA San Pablo Oncologic Hospital Caguas, , Puerto Rico, 00726
    • San Jorge Children's Hospital San Juan, , Puerto Rico, 00912
    • University Pediatric Hospital San Juan, , Puerto Rico, 00926
  • Saudi Arabia,
    • King Faisal Specialist Hospital and Research Centre Riyadh, , Saudi Arabia, 11211
  • Sweden, Scania
    • Skane University Hospital Lund, Scania, Sweden, 22185
  • Switzerland,
    • University Children's Hospital Zurich, , Switzerland, CH8032

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

EsPhALL network I-BFM Study Group

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03007147
Other Study ID Numbers: NCI-2016-01588
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Philadelphia Chromosome

Calcium, Dietary

Leucovorin

Folic Acid

Cytarabine

Dexamethasone

Dexamethasone acetate

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone

Prednisolone acetate

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Cyclophosphamide

Ifosfamide

Isophosphamide mustard

Doxorubicin

Liposomal doxorubicin

Methotrexate

Etoposide

Vincristine

Etoposide phosphate

Imatinib Mesylate

Daunorubicin

Asparaginase

Mercaptopurine

Podophyllotoxin

Pegaspargase

Thioguanine

Dexrazoxane

Razoxane

Azathioprine

Lenograstim

Prednisolone hemisuccinate

Prednisolone phosphate

BB 1101

Calcium

2-Aminopurine

Levoleucovorin

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on February 25, 2021