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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	7 November 2022
Main ID:	NCT02448095
Date of registration:	15/05/2015
Prospective Registration:	Yes
Primary sponsor:	Gruppo Italiano Malattie EMatologiche dell'Adulto
Public title:	Retrospective Evaluation of CML Patients in the National Compassionate Program
Scientific title:	Ponatinib Survey: Retrospective Evaluation of CML Patients in the National Compassionate Program According to the 648/96 Decree
Date of first enrolment:	December 22, 2015
Target sample size:	38
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT02448095
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Italy

Contacts

Name:	Carmen Fava
Address:
Telephone:
Email:
Affiliation:	Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2 - Orbassano

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Myeloid Leukemia

Philadelphia Positive

Intervention(s)

Drug: Ponatinib

Primary Outcome(s)

Number of adverse events [Time Frame: Maximum of 60 months from treatment start]

Secondary Outcome(s)

Number of patients in event free survival [Time Frame: 12 months after patient enrollment in the study]

Number of patients with hematological complete response [Time Frame: Maximum of 60 months from treatment start]

Total number of patients alive [Time Frame: 12 months after patient enrollment in the study]

Number of mutations [Time Frame: Maximum of 60 months from treatment start]

Number of patients in progression free survival [Time Frame: 12 months after patient enrollment in the study]

Number of days from treatment start till response [Time Frame: Maximum of 60 months from treatment start]

Number of units of Ponatinib administered per units of time [Time Frame: Maximum of 60 months from treatment start]

Secondary ID(s)

CML1214

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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