Retrospective Evaluation of CML Patients in the National Compassionate Program

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Terminated

Conditions: Philadelphia Positive; Chronic Myeloid Leukemia

Treatments: Drug: Ponatinib

Study type: Observational

Funder types: Other

Identifiers

NCT02448095

CML1214

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

38 participants in 1 patient group

CML ph+ patients

Description:

Chronic myeloid leukemia patients who are philadelphia positive

Treatment:

Drug: Ponatinib