Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia
Eligibility Criteria
Inclusion Criteria:
Diagnostic samples will be collected and analyzed according to the procedures of the National front-line protocol
- Patients should be enrolled on National ALL protocol prior to enrollment on EsPhALL2017/COGAALL1631. Regardless of initial front-line protocol baseline diagnostic samples must be available to develop an MRD probe
- BCR-ABL1 fusion (Ph+): newly diagnosed 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
ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions identified according to National/Center procedures of each participating country. ABL-class fusions are defined as those involving the following genes: ABL1, ABL2, CSF1R, PDGFRB, PDGFRA, LYN. Methods of detection include fluorescence in-situ hybridization (FISH, e.g. using break-apart or colocalization signals probes), multiplex or singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole transcriptome or panel-based ribonucleic acid (RNA)-sequencing
- Regardless of initial front-line protocol, laboratory reports detailing evidence of BCR-ABL1 or ABL-class fusion must be available for the National Trial Unit
- Ph+ ALL patients must have previously started induction therapy, which includes vincristine, a corticosteroid, usually PEG-L-asparaginase, with or without anthracycline, and/or other standard cytotoxic chemotherapy
- Ph+ ALL patients have not received more than 14 days of multiagent induction therapy beginning with the first dose of vincristine
- Ph+ ALL patients may have started imatinib prior to study entry but have not received more than 14 days of imatinib
- ABL-class fusion patients must have previously completed the 4 or 5 weeks of multiagent Induction chemotherapy
- ABL-class fusion patients may have started imatinib during Induction IA, at the same time of or after the first vincristine dose
- 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 and electrocardiogram are not required if they were performed at or after initial ALL diagnosis, before study enrollment
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or 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 treatment according to protocol
- Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block
- Prior treatment with dasatinib, or any TKI inhibitor other than imatinib
- All patients and/or their parents or legal guardians must sign a written informed consent
Sites / Locations
- Children's Hospital of AlabamaRecruiting
- USA Health Strada Patient Care CenterRecruiting
- Providence Alaska Medical CenterRecruiting
- Banner Children's at DesertRecruiting
- Phoenix Childrens HospitalRecruiting
- Banner University Medical Center - TucsonRecruiting
- Arkansas Children's HospitalRecruiting
- Kaiser Permanente Downey Medical CenterRecruiting
- City of Hope Comprehensive Cancer CenterRecruiting
- Loma Linda University Medical CenterRecruiting
- Miller Children's and Women's Hospital Long BeachRecruiting
- Children's Hospital Los AngelesRecruiting
- Cedars Sinai Medical CenterRecruiting
- Valley Children's HospitalRecruiting
- UCSF Benioff Children's Hospital OaklandRecruiting
- Kaiser Permanente-OaklandRecruiting
- Children's Hospital of Orange CountyRecruiting
- Lucile Packard Children's Hospital Stanford UniversityRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- Rady Children's Hospital - San DiegoRecruiting
- UCSF Medical Center-Mission BayRecruiting
- Children's Hospital ColoradoRecruiting
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical CenterRecruiting
- Connecticut Children's Medical CenterRecruiting
- Yale UniversityRecruiting
- Alfred I duPont Hospital for ChildrenRecruiting
- MedStar Georgetown University Hospital
- Children's National Medical CenterRecruiting
- Broward Health Medical CenterRecruiting
- Golisano Children's Hospital of Southwest FloridaRecruiting
- University of Florida Health Science Center - GainesvilleRecruiting
- Memorial Regional Hospital/Joe DiMaggio Children's HospitalRecruiting
- Nemours Children's Clinic-JacksonvilleRecruiting
- Palms West Radiation Therapy
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- Nicklaus Children's HospitalRecruiting
- Miami Cancer InstituteRecruiting
- AdventHealth OrlandoRecruiting
- Arnold Palmer Hospital for ChildrenRecruiting
- Nemours Children's HospitalRecruiting
- Sacred Heart HospitalRecruiting
- Johns Hopkins All Children's HospitalRecruiting
- Tampa General HospitalRecruiting
- Saint Joseph's Hospital/Children's Hospital-TampaRecruiting
- Saint Mary's HospitalRecruiting
- Children's Healthcare of Atlanta - EglestonRecruiting
- Augusta University Medical CenterRecruiting
- Medical Center of Central GeorgiaRecruiting
- Memorial Health University Medical CenterRecruiting
- Kapiolani Medical Center for Women and ChildrenRecruiting
- Saint Luke's Cancer Institute - BoiseRecruiting
- Lurie Children's Hospital-ChicagoRecruiting
- University of IllinoisRecruiting
- University of Chicago Comprehensive Cancer CenterRecruiting
- Advocate Children's Hospital-Oak LawnRecruiting
- Advocate Children's Hospital-Park RidgeRecruiting
- Saint Jude Midwest AffiliateRecruiting
- Southern Illinois University School of MedicineRecruiting
- Riley Hospital for ChildrenRecruiting
- Ascension Saint Vincent Indianapolis HospitalRecruiting
- Blank Children's HospitalRecruiting
- University of Iowa/Holden Comprehensive Cancer CenterRecruiting
- University of Kentucky/Markey Cancer CenterRecruiting
- Norton Children's HospitalRecruiting
- Ochsner Medical Center Jefferson
- Eastern Maine Medical Center
- Maine Children's Cancer ProgramRecruiting
- Sinai Hospital of BaltimoreRecruiting
- Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
- Walter Reed National Military Medical CenterRecruiting
- Tufts Children's Hospital
- Massachusetts General Hospital Cancer CenterRecruiting
- Dana-Farber Cancer InstituteRecruiting
- UMass Memorial Medical Center - University CampusRecruiting
- C S Mott Children's HospitalRecruiting
- Ascension Saint John Hospital
- Michigan State University Clinical CenterRecruiting
- Helen DeVos Children's Hospital at Spectrum HealthRecruiting
- Bronson Methodist HospitalRecruiting
- Beaumont Children's Hospital-Royal OakRecruiting
- Children's Hospitals and Clinics of Minnesota - MinneapolisRecruiting
- University of Minnesota/Masonic Cancer CenterRecruiting
- Mayo Clinic in Rochester
- University of Mississippi Medical CenterRecruiting
- Columbia RegionalRecruiting
- Children's Mercy Hospitals and ClinicsRecruiting
- Washington University School of MedicineRecruiting
- Mercy Hospital Saint LouisRecruiting
- Children's Hospital and Medical Center of OmahaRecruiting
- University of Nebraska Medical CenterRecruiting
- University Medical Center of Southern NevadaRecruiting
- Sunrise Hospital and Medical CenterRecruiting
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
- Summerlin Hospital Medical CenterRecruiting
- Renown Regional Medical CenterRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- Hackensack University Medical Center
- Morristown Medical CenterRecruiting
- Saint Peter's University HospitalRecruiting
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalRecruiting
- Newark Beth Israel Medical CenterRecruiting
- Saint Joseph's Regional Medical CenterRecruiting
- University of New Mexico Cancer CenterRecruiting
- Presbyterian HospitalRecruiting
- Albany Medical CenterRecruiting
- Montefiore Medical Center - Moses CampusRecruiting
- Maimonides Medical CenterRecruiting
- Roswell Park Cancer InstituteRecruiting
- NYU Winthrop HospitalRecruiting
- The Steven and Alexandra Cohen Children's Medical Center of New YorkRecruiting
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneRecruiting
- Mount Sinai HospitalRecruiting
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- University of RochesterRecruiting
- Stony Brook University Medical CenterRecruiting
- State University of New York Upstate Medical UniversityRecruiting
- New York Medical CollegeRecruiting
- Mission HospitalRecruiting
- UNC Lineberger Comprehensive Cancer CenterRecruiting
- Carolinas Medical Center/Levine Cancer InstituteRecruiting
- Novant Health Presbyterian Medical CenterRecruiting
- Duke University Medical CenterRecruiting
- East Carolina UniversityRecruiting
- Wake Forest University Health SciencesRecruiting
- Sanford Broadway Medical CenterRecruiting
- Children's Hospital Medical Center of AkronRecruiting
- Cincinnati Children's Hospital Medical CenterRecruiting
- Rainbow Babies and Childrens HospitalRecruiting
- Cleveland Clinic FoundationRecruiting
- Nationwide Children's HospitalRecruiting
- Dayton Children's HospitalRecruiting
- ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Oregon Health and Science UniversityRecruiting
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Geisinger Medical CenterRecruiting
- Penn State Children's HospitalRecruiting
- Children's Hospital of PhiladelphiaRecruiting
- Saint Christopher's Hospital for ChildrenRecruiting
- Children's Hospital of Pittsburgh of UPMCRecruiting
- Rhode Island HospitalRecruiting
- Medical University of South CarolinaRecruiting
- Prisma Health Richland HospitalRecruiting
- BI-LO Charities Children's Cancer CenterRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- T C Thompson Children's HospitalRecruiting
- East Tennessee Childrens HospitalRecruiting
- The Children's Hospital at TriStar CentennialRecruiting
- Vanderbilt University/Ingram Cancer CenterRecruiting
- Texas Tech University Health Sciences Center-AmarilloRecruiting
- Dell Children's Medical Center of Central TexasRecruiting
- Driscoll Children's HospitalRecruiting
- Medical City Dallas HospitalRecruiting
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- El Paso Children's HospitalRecruiting
- Cook Children's Medical CenterRecruiting
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
- M D Anderson Cancer CenterRecruiting
- Covenant Children's HospitalRecruiting
- UMC Cancer Center / UMC Health SystemRecruiting
- Children's Hospital of San AntonioRecruiting
- Methodist Children's Hospital of South TexasRecruiting
- University of Texas Health Science Center at San AntonioRecruiting
- Scott and White Memorial HospitalRecruiting
- Primary Children's HospitalRecruiting
- University of Vermont and State Agricultural CollegeRecruiting
- University of Virginia Cancer CenterRecruiting
- Inova Fairfax HospitalRecruiting
- Children's Hospital of The King's DaughtersRecruiting
- Naval Medical Center - PortsmouthRecruiting
- Virginia Commonwealth University/Massey Cancer CenterRecruiting
- Carilion Children'sRecruiting
- Seattle Children's HospitalRecruiting
- Providence Sacred Heart Medical Center and Children's HospitalRecruiting
- Mary Bridge Children's Hospital and Health CenterRecruiting
- Madigan Army Medical CenterRecruiting
- Edwards Comprehensive Cancer CenterRecruiting
- West Virginia University HealthcareRecruiting
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Children's Hospital of WisconsinRecruiting
- John Hunter Children's HospitalRecruiting
- Sydney Children's HospitalRecruiting
- The Children's Hospital at WestmeadRecruiting
- Queensland Children's HospitalRecruiting
- Princess Margaret Hospital for Children
- Perth Children's HospitalRecruiting
- St. Anna Children's HospitalRecruiting
- Hospitals LeuvenRecruiting
- Alberta Children's HospitalRecruiting
- University of Alberta HospitalRecruiting
- British Columbia Children's HospitalRecruiting
- CancerCare ManitobaRecruiting
- IWK Health CentreRecruiting
- McMaster Children's Hospital at Hamilton Health SciencesRecruiting
- Kingston Health Sciences CentreRecruiting
- Children's HospitalRecruiting
- Children's Hospital of Eastern OntarioRecruiting
- Hospital for Sick ChildrenRecruiting
- The Montreal Children's Hospital of the MUHCRecruiting
- Centre Hospitalier Universitaire Sainte-JustineRecruiting
- Centre Hospitalier Universitaire de Sherbrooke-FleurimontRecruiting
- Jim Pattison Children's HospitalRecruiting
- Saskatoon Cancer Centre
- Centre Hospitalier Universitaire de QuebecRecruiting
- Hospital Roberto del Rio-Universidad de ChileRecruiting
- University Hospital MotolRecruiting
- Tampere University HospitalRecruiting
- CHU Hopital SudRecruiting
- Universitatsklinik EppendorfRecruiting
- University Medical Center Chleswig-Campus KielRecruiting
- Hong Kong Children's HospitalRecruiting
- Schneider Children's Medical Center of IsraelRecruiting
- Prof Andrea BiondiRecruiting
- Princess Maxima Center for Pediatric OncologyRecruiting
- Starship Children's HospitalRecruiting
- Christchurch HospitalRecruiting
- HIMA San Pablo Oncologic HospitalRecruiting
- San Jorge Children's Hospital
- University Pediatric HospitalRecruiting
- King Faisal Specialist Hospital and Research Centre
- Skane University HospitalRecruiting
- University Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm A (imatinib mesylate, EsPhALL chemotherapy)
Arm B (imatinib mesylate, COG/BFM chemotherapy)
Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
See Detailed Description
See Detailed Description.
See Detailed Description