| 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 |
| Type(s) de cancer |
Pédiatrique divers |
| Phase |
Phase III |
| Médicament |
imatinib |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 CHUL ET CENTRE MERE-ENFANT SOLEIL
2705 boulevard Laurier, Québec, QC, G1V 4G2
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dr Bruno Michon
|
| Coordonnateur(trice) |
Barbara Desbiens
418-525-4444 poste 40195
|
| Statut |
 Actif en recrutement |
| 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
|
Groupe d'étude en oncologie du Québec