Very High-Risk T-Lineage Acute Lymphoblastic Leukemia (ALL)
Conditions
Brief summary
The primary endpoint of this study is to evaluate clinical response - in terms of MRD negativity (<10^-4) after induction (TP1) - in patients with very high-risk T-ALL treated with a daratumumab plus chemotherapy approach.
Detailed description
The rate of MRD negativity at TP2, TP3, TP4 and before allo-SCT, The rate of allo-SCT allocation, DFS at 12 months, EFS at 18 months, CIR estimation from CR achievement at 18 months, OS at 18 months, Treatment-related mortality (TRM), Rate of Adverse Events (AEs) and Serious AEs
Interventions
DRUGAPREPITANT
DRUGLEVOCARNITINE
DRUGCYCLOPHOSPHAMIDE
DRUGGRANISETRON
DRUGSALBUTAMOL
DRUGGANCICLOVIR
DRUGAMPHOTERICIN B
DRUGALLOPURINOL
DRUGDARZALEX 1800 mg solution for injection
DRUGHUMAN FIBRINOGEN
DRUGCYTARABINE
DRUGDEXAMETHASONE SODIUM PHOSPHATE
DRUGVINCRISTINE SULFATE
DRUGPARACETAMOL
DRUGMONTELUKAST
DRUGFILGRASTIM
DRUGLEVOFLOXACIN
DRUGRASBURICASE
DRUGMETHOTREXATE
DRUGHYDROCORTISONE
DRUGFOSCARNET
DRUGMETHYLPREDNISOLONE SODIUM SUCCINATE
DRUGLENOGRASTIM
DRUGPEGASPARGASE
DRUGMICAFUNGIN
DRUGACICLOVIR
DRUGCHLORPHENAMINE
DRUGCIPROFLOXACIN
DRUGDIPHENHYDRAMINE
DRUGFUROSEMIDE
DRUGCO-TRIMOXAZOLE
DRUGMERCAPTOPURINE
DRUGFOLINIC ACID
DRUGPREDNISONE
DRUGONDANSETRON
Sponsors
Fondazione Gimema Franco Mandelli Onlus
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is to evaluate clinical response - in terms of MRD negativity (<10^-4) after induction (TP1) - in patients with very high-risk T-ALL treated with a daratumumab plus chemotherapy approach. | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of MRD negativity at TP2, TP3, TP4 and before allo-SCT, The rate of allo-SCT allocation, DFS at 12 months, EFS at 18 months, CIR estimation from CR achievement at 18 months, OS at 18 months, Treatment-related mortality (TRM), Rate of Adverse Events (AEs) and Serious AEs | — |
Countries
Italy
Outcome results
None listed