• GEOQ
Titre International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones
Protocole ID COG-AALL1631
ClinicalTrials.gov ID NCT03007147
Site Anatomique Pédiatrique divers
Phase Phase III
Stade
Type étude
Médicament imatinib
Institution CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
Ville Montréal
Investigateur principal Dr Yvan Samson
Coordonnateur Frédéric Ancot
Statut Actif en recrutement
Date d'activation
Critètes d'éligibilité
  • Patients who have not previously enrolled on AALL08B1 or APEC14B1 (if open for classification of newly diagnosed ALL patients) prior to enrollment on AALL1631, a baseline diagnostic sample must be available to develop an MRD probe
  • Newly diagnosed de novo ALL (B-ALL or T-ALL) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR
    • For patients who DO NOT enter AALL1631 via AALL08B1 or APEC14B1 (if open for classification of newly diagnosed ALL patients), laboratory reports detailing evidence of BCR-ABL1 fusion must be submitted for rapid central review within 72 hours of study enrollment
    • Patients with known chronic myelogenous leukemia (CML) who develop lymphoid blast crisis are not eligible
  • 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 induction therapy
  • Patient has not had prior treatment with imatinib, dasatinib, or any other BCR-ABL1 inhibitor
  • Karnofsky/Lansky performance status >= 60; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • 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)
Critètes d'exclusion
  • 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; 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