Newly Diagnosed Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL). Sequential Treatment With Ponatinib and the Bispecific Monoclonal Antibody Blinatumomab vs Chemotherapy and Imatinib

NCT04722848 Phase 3 ACTIVE_NOT_RECRUITING

This is a randomised, open-label, multicenter, phase III study for adult de novo Ph+ ALL patients based on the combination of Ponatinib with Blinatumomab. The control arm will be represented by a chemotherapeutic scheme combined with Imatinib for patients aged 18-65 and by Imatinib plus age-adjusted chemotherapy for elderly patients (\>65 years old). Patients will be randomized 2:1 to receive the experimental or control arm. If patients in the control arm do not achieve a CHR and/or MRD negativity, after the sixth consolidation cycle (week 20), a crossover to receive Blinatumomab is planned. Likewise, if patients in the control arm develop an ABL1 mutation at any time of treatment, they will switch to experimental arm. HLA typing will be performed immediately after diagnosis in both arms for patients aged up to 65 years. After the 2 cycles of Blinatumomab in the experimental arm and after consolidation in the control arm, patients aged 18-65 will be stratified for transplant allocation.

Details

Lead sponsor	Gruppo Italiano Malattie EMatologiche dell'Adulto
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	236
Start date	2021-09-08
Completion	2027-09

Conditions

• Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)
• ALL, Adult
• Philadelphia-Positive ALL

Interventions

• Ponatinib + Blinatumomab
• Chemotherapy + Imatinib

Primary outcomes

• Number of patients who are event-free — at 5 months
  event-free survival rate

Countries

Italy