Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.
Conditions
Brief summary
The primary endpoint of this study is to evaluate the efficacy of a sequential approach based on the administration of Ponatinib plus and Blinatumomab vs chemotherapy combined with Imatinib, in terms of (EFS), a composite endpoint, with events defined as: non achievement of MRD negativity (CMR or PNQ), deaths for any reason, toxicity and resistance (due or not to an ABL1 mutation development) in adult Ph+ ALL (=18 years, no upper age limit).
Detailed description
The feasibility of patients’ stratification to allo-SCT allocation on the basis of a refined MRD evaluation and on the presence/absence of IKZF1-plus)., Capability of Blinatumomab to further reduce the MRD levels after Ponatinib induction., CMR or PNQ duration., DFS at 1 and 3 years., OS at 1 and 3 years., CIR., Safety profile. Safety profile in terms of incidence of grade =3 CTC-NCI side effects and toxicities., Comparison of patients’ quality of life (QoL) profiles over time by randomization arms.
Interventions
DRUGMETHOTREXATE
DRUGIdarubicina Sandoz 1 mg/ml concentrato per soluzione per infusione
DRUGPREDNISONE
DRUGCYCLOPHOSPHAMIDE
DRUGFILGRASTIM
DRUGCYTARABINE
DRUGMETHYLPREDNISOLONE SODIUM SUCCINATE
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 the efficacy of a sequential approach based on the administration of Ponatinib plus and Blinatumomab vs chemotherapy combined with Imatinib, in terms of (EFS), a composite endpoint, with events defined as: non achievement of MRD negativity (CMR or PNQ), deaths for any reason, toxicity and resistance (due or not to an ABL1 mutation development) in adult Ph+ ALL (=18 years, no upper age limit). | — |
Secondary
| Measure | Time frame |
|---|---|
| The feasibility of patients’ stratification to allo-SCT allocation on the basis of a refined MRD evaluation and on the presence/absence of IKZF1-plus)., Capability of Blinatumomab to further reduce the MRD levels after Ponatinib induction., CMR or PNQ duration., DFS at 1 and 3 years., OS at 1 and 3 years., CIR., Safety profile. Safety profile in terms of incidence of grade =3 CTC-NCI side effects and toxicities., Comparison of patients’ quality of life (QoL) profiles over time by randomization arms. | — |
Countries
Italy
Outcome results
None listed