Retrospective Evaluation of CML Patients in the National Compassionate Program

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This observational study aims at assessing the tolerability and safety profiles of Ponatinib, a drug used for Chronic Myeloid Leukemia patients who are Philadelphia positive. This drug is used during the chronic phase of the disease, according to the Italian national compassionate law 648/96.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Treatments: Ponatinib

Criteria

Inclusion Criteria:

• CML Ph+ patients in chronic phase

• 18 years old or older

• Patients have received either Dasatinib or Nilotinib and resulted resistant or not tolerant to the drugs or have developed the T3151 mutation

• Patients have started Ponatinib at least 12 months before registration

• Informed consent signed at registration

Exclusion Criteria:

• CML Ph+ patients in accelerated or blast phase with acute lymphoblastic leukemia