NCT04475731

Ponatinib in Adult Ph+ ALL Patients With MRD Positivity or Hematological Relapse

Ponatinib for the Management of Minimal Residual Disease (MRD) and Hematologic Relapse in Adult Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) Patients

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II interventional trial to evaluate if the use of ponatinib, with or without chemotherapy, can induce a molecular remission in MRD-positive patients, in patients in hematologic and extra-hematologic relapse and in the few patients who never achieved an hematologic remission after whatever prior treatment.

Detailed description

This is a phase II interventional multicenter study for adult patients with Ph+ALL who: * Are MRD+ (i.e. BCR-ABL1/ABL1 \>0.01) (or loose their molecular response) after whichever kind of previous treatment. MRD positivity is indeed regarded as a relapse/resistance, since it represents the early recognition of cases who will eventually experience an hematologic recurrence of disease. * Are in hematologic relapse after whichever kind of previous treatment. * Have never achieved an hematologic remission at least after one month of treatment. Patients will be treated with Ponatinib at a dose of 45 mg/die per os for 28 days for 3 cycles and - if in hematologic and extra-hematologic relapse/refractoriness, clinically fit and according to medical decision - with concurrent systemic chemotherapy. In case of CMR achievement, dosing will be reduced to 30 mg. In case of toxicity, Ponatinib will be reduced to 30 (or 15) mg daily.

Conditions

• Philadelphia-Positive ALL
• Acute Lymphoblastic Leukemia, in Relapse

Interventions

Type	Name	Description
DRUG	Ponatinib	Ponatinib 45 mg/day x 4 weeks x 3 courses. +/- chemotherapy: * vincristine or * L-VAMP (leucovorin, vincristine, aracytin, methotrexate, prednisone)

Timeline

• Start date: 2021-05-04
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2020-07-17
• Last updated: 2024-10-22

Locations

22 sites across 1 country: Italy