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

Acute Lymphoblastic Leukemia, in Relapse Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia, in Relapse
• Leukemia
• Leukemia, Lymphoid
• Philadelphia-Positive ALL
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Recurrence

• NCT number: NCT04475731
• Study type: Interventional
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: Paola Fazi
• Phone: 0670390528
• Email: p.fazi@gimema.it
• Status: Recruiting
• Phase: Phase 2
• Start date: May 4, 2021
• Completion date: November 2024