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

NCT04475731 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2024-10-22

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Ponatinib

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

Sponsors & Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-04
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04475731 on ClinicalTrials.gov