Retrospective Evaluation of CML Patients in the National Compassionate Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-22

Study Completion Date

2018-07-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Myeloid Leukemia Philadelphia Positive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CML ph+ patients

Chronic myeloid leukemia patients who are philadelphia positive

Ponatinib

Intervention Type DRUG

Observation of tolerability and safety profiles

Interventions

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Ponatinib

Observation of tolerability and safety profiles

Intervention Type DRUG

Eligibility Criteria

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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