| TITRE |
(EN) A Phase 2/3 Multicenter, Open-label, 3-arm, 2-Stage Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy |
| PROTOCOLE ID |
2215-CL-0201 |
| CLINICAL TRIAL.gov ID |
NCT02752035 |
| TYPE(S) DE CANCER |
Leucémie myéloïde aiguë (LMA) |
| PHASE |
Phase II |
| TYPE D'ÉTUDE |
|
| INSTITUTION |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
John Storring
|
| COORDONATEUR(RICE) |
Lorena Iglesias
lorena.iglesias@muhc.mcgill.ca
514-934-1934 poste 34907
|
| STATUT |
Fermé
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Subject is considered an adult according to local regulation at the time of obtaining informed consent.
- Subject has a diagnosis of previously-untreated AML according to World Health Organization (WHO) classification [Swerdlow et al, 2008] as determined by pathology review at the treating institution.
- Subject is positive for FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD] [D835/I836] mutation) in bone marrow or whole blood as determined by central laboratory. Note: Only applicable to the randomization portion.
-
Subject is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:
- Subject is ≥ 75 years of age.
-
Subject has any of the following comorbidities:
- Congestive heart failure (New York Heart Association {NYHA} class ≤ 3) or ejection fraction (Ef) ≤ 50%;
- Creatinine > 2 mg/dL (177 µmol/L), dialysis or prior renal transplant;
- ECOG performance status ≥ 3;
- Prior or current malignancy that does not require concurrent treatment;
- Subject has received a cumulative anthracycline dose above 400 mg/m2 of doxorubicin (or cumulative maximum dose of another anthracycline).
-
Subject must meet the following criteria as indicated on the clinical laboratory tests:
- Serum AST and ALT ≤ 2.5 x Institutional upper limit of normal (ULN)
- Serum total bilirubin ≤ 1.5 x Institutional ULN
- Serum potassium ≥ Institutional lower limit of normal (LLN)
- Serum magnesium ≥ Institutional LLN
- Subject is suitable for oral administration of study drug.
-
Female subject must either:
- Be of nonchildbearing potential:
- Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
- Documented surgically sterile or status posthysterectomy (at least 1 month prior to screening)
-
Or, if of childbearing potential,
- Agree not to try to become pregnant during the study and for 180 days after the final study drug administration
- And have a negative urine or serum pregnancy test at screening
- And, if heterosexually active, agree to consistently use 2 forms of effective contraception per locally accepted standards, 1 of which must be a barrier method, starting at screening and throughout the study period and for 180 days after the final study drug administration.
- Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 60 days after the final study drug administration.
- Female subject must not donate ova starting at screening and throughout the study period, and for 180 days after the final study drug administration.
- Male subject and their female partners who are of childbearing potential must be using 2 forms of effective contraception per locally accepted standards, 1 of which must be a barrier method, starting at screening and continue throughout the study period, and for 120 days after the final study drug administration.
- Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration.
- Subject agrees not to participate in another interventional study while on treatment.
|
| CRITÈRES D'EXCLUSION |
(EN)
|
