Adult Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia.
Conditions
Brief summary
The primary endpoint of this study is to evaluate clinical response - in terms of MRD negativity rate after 3 cycles (TP2) in patients with BCR/ABL1-like ALL treated with a Ponatinib plus chemotherapy approach.
Detailed description
The rate of MRD negativity at 2 timepoints TP1, TP3, DFS at 24 months, EFS at 24 months, CIR estimation from CR achievement at 24 months, OS at 24 months, Treatment-related mortality (TRM), Rate of patients in CR after TP2, Rate of patients who undego transplantion and who complete the Chemotherapy plus ponatinib scheme, Rate of Adverse Events (AEs) and Seriuos AEs related to Ponatinib
Interventions
DRUGMERCAPTOPURINE
DRUGPREDNISONE
DRUGVINCRISTINE SULFATE
DRUGCYTARABINE
DRUGFILGRASTIM
DRUGLENOGRASTIM
DRUGFOLINIC ACID
DRUGMETHYLPREDNISOLONE SODIUM SUCCINATE
DRUGCYCLOPHOSPHAMIDE
DRUGMETHOTREXATE
DRUGDEXAMETHASONE DISODIUM PHOSPHATE
Sponsors
Fondazione Gimema Franco Mandelli Onlus
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is to evaluate clinical response - in terms of MRD negativity rate after 3 cycles (TP2) in patients with BCR/ABL1-like ALL treated with a Ponatinib plus chemotherapy approach. | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of MRD negativity at 2 timepoints TP1, TP3, DFS at 24 months, EFS at 24 months, CIR estimation from CR achievement at 24 months, OS at 24 months, Treatment-related mortality (TRM), Rate of patients in CR after TP2, Rate of patients who undego transplantion and who complete the Chemotherapy plus ponatinib scheme, Rate of Adverse Events (AEs) and Seriuos AEs related to Ponatinib | — |
Countries
Italy
Outcome results
None listed