Białaczka: badanie fazy III leku blinatumomab i dexamethasone phosphate

Kryteria wyłączenia kto nie może wziąć udziału (22)

1. Known hypersensitivity to the active substances or excipients of the IMP’s or the SOC drugs, except to PEG-asparaginase which can be replaced by Erwinase
2. Relapse post chimeric antigen receptor T-cell (CAR-T) therapy
3. The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
4. Objection to the study participation by a minor patient
5. Patients in a dependent or subordinate relationship to the investigator or site staff (e.g. employees, relatives, or students)
6. Specific for SR induction randomization: Prior confirmed severe (grade 3 or 4) or ongoing VOD/SOS
7. Specific for SR induction randomization: Serious ongoing hepatic disease (e.g., cirrhosis, active hepatitis) not related to the current ALL relapse or current diagnostic/therapeutic measures
8. Specific for SR induction randomization: ALT > 2,5 x ULN (at relapse diagnosis before start of cytoreduction) and/or bilirubin > 1.5 x ULN
9. No consent is given for saving and propagation of pseudonymized medical data for study reasons
10. Left ventricular ejection fraction (LVEF) < 50% or fractional shortening < 25%, and/or current or prior treatment for cardiomyopathy and/or history of clinically significant arrhythmias
11. Severe concomitant disease that, according to the treating physician, does not allow treatment according to the protocol at the investigator’s discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
12. Subjects unwilling or unable to comply with the study procedures
13. Subjects who are legally detained in an official institute
14. Pregnancy or positive pregnancy test in female patients (urine sample positive for β-HCG > 10 U/l) at screening or within 7 days prior to the initiation of study treatment
15. Sexually active adolescents and adults not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
16. Women not willing to refrain from Bbreast feeding until 12 months after end of anti-leukemic therapy
17. Relapse post allogeneic HSCT
18. Patients with any concurrent medical condition, laboratory abnormality, concomitant treatment, or comorbidity that, in the investigator’s clinical judgment would- compromise the patient’s ability to safely receive or tolerate inotuzumab ozogamicin and/or blinatumomab - significantly interfere with assessment of treatment efficacy or safety - make it unlikely that the patient would derive clinical benefit from protocol therapy - preclude adherence to study procedures or follow-up requirements
19. Specific for SR induction randomization: Patients with intolerance to PEG-asparagniase and also to Erwinase are stratified to the inotuzumab arm
20. Specific for SR induction randomization: Patients with insufficient expression of CD22 (< 80%) on leukemic blasts, they are assigned to the control chemotherapy arm
21. Specific for blinatumomab treatment: Clinically relevant CNS pathology requiring treatment (eg, unstable epilepsy)
22. Specific for blinatumomab treatment: Evidence of current CNS (CNS 2, CNS 3) involvement by ALL. Subjects with CNS relapse at the time of relapse are eligible if CNS is successfully treated prior to enrollment