Retrospective Evaluation of CML Patients in the National Compassionate Program

Chronic Myeloid Leukemia Clinical Trial

Official title:

Ponatinib Survey: Retrospective Evaluation of CML Patients in the National Compassionate Program According to the 648/96 Decree

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02448095
• Other study ID #: CML1214
• Status: Terminated
• Start date: December 22, 2015
• Est. completion date: July 17, 2018

Study information

• Verified date: October 2022
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: July 17, 2018
• Est. primary completion date: July 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Philadelphia Positive

Intervention

Drug:
• Ponatinib
Observation of tolerability and safety profiles

Locations

Country	Name	City	State
Italy	UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro	Bari
Italy	IRCCS_AOU San Martino-IST.Clinica Ematologica	Genova
Italy	ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE	Lecce
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano	Milano
Italy	Azienda Ospedaliera "S.Gerardo"	Monza
Italy	S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro	Novara
Italy	Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2 - Orbassano	Orbassano
Italy	S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo	Pavia
Italy	Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"	Reggio Calabria
Italy	U.O.C. Ematologia - Ospedale S. Eugenio	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events	General adverse events and grade 3-4 adverse events according to NCI CTCAE version 4.0	Maximum of 60 months from treatment start
Secondary	Number of patients with hematological complete response	Hematological complete response and related responses, such as major cytogenetic response, complete cytogenetic response and major molecular response.	Maximum of 60 months from treatment start
Secondary	Number of days from treatment start till response		Maximum of 60 months from treatment start
Secondary	Total number of patients alive	Overall survival	12 months after patient enrollment in the study
Secondary	Number of patients in event free survival	Event free survival	12 months after patient enrollment in the study
Secondary	Number of patients in progression free survival	Progression free survival	12 months after patient enrollment in the study
Secondary	Number of mutations	Both at the beginning and at the end of treatment	Maximum of 60 months from treatment start
Secondary	Number of units of Ponatinib administered per units of time	Chemotherapy dose intensity represents unit dose of chemotherapy administered per unit time.	Maximum of 60 months from treatment start

External Links

•   GIMEMA Foundation website