Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib

Chronic Myeloid Leukaemia Clinical Trial

— CML0609  

Official title:

Observational Study in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia (CML) Treated With Nilotinib: Follow-up of the Italian Patients. GIMEMA Study CML0609

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475110
• Other study ID #: CML0609
• Status: Completed
• Start date: September 13, 2012
• Est. completion date: November 24, 2016

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

The GIMEMA CML Working Party promotes an observational (retrospective and perspective) study of Imatinib-resistant or intolerant CML patients treated with Nilotinib in Italy. Enrollment will include all patients who started Nilotinib between January 2005 and December 2012. Patients will be followed for 4 years since treatment start. After this time, survival data, disease status and treatment will be recorded at 6-months-interval. This study will help the definition of guidelines for a proper management of Nilotinib in any-phase CML patients.

Description:

Follow-up is required until the end of treatment for the purposes of the study for all patients by standard hematologic, cytogenetic and molecular criteria. This study will not contemplate any additional expense beyond what is expected for a regular follow-up, according to the international guidelines for CML. Sample Size: target accrual was not defined, all eligible patients observed between January 2005 and December 2012 will be included.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 24, 2016
• Est. primary completion date: November 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with Imatinib resistant (failure + suboptimal) or intolerant chronic myeloid leukaemia in all phases, who started treatment with Nilotinib between January 2005 and December 2012 in Italy.
• Adult pts treated with Nilotinib as second line therapy after Dasatinib.

Exclusion Criteria:

• Patients less than 18 year old.
• Use of Nilotinib as first line treatment.
• Patients treated with Nilotinib before 2005.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Imatinib
Observation of Imatinib resistant patients treated with Nilotinib.

Locations

Country	Name	City	State
Italy	Ospedale	Alessandria
Italy	S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	S.G. Moscati Hospital	Avellino
Italy	Ospedale	Bari
Italy	Ospedale	Bologna
Italy	Azienda Spedali Civili	Brescia
Italy	Ospedale Ferrarotto	Catania
Italy	Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna	Ferrara
Italy	Policlinico di Careggi, Università delgi studi di Firenze	Firenze
Italy	Clinica Ematologica - Università degli Studi	Genova
Italy	Università degli Studi	Genova
Italy	Università di Genova	Genova
Italy	ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia	Lecce
Italy	A.O. Universitaria Policlinico Martina di Messina	Messina
Italy	U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele	Milano
Italy	Federico II	Napoli
Italy	Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10	Orbassano
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone	Palermo
Italy	Ospedale Cervello	Palermo
Italy	Dipartimento Oncologico - Ospedale S.Maria delle Croci	Ravenna
Italy	Ospedale	Reggio Calabria
Italy	Ospedale	Rimini
Italy	Centro Oncologico Basilicata	Rionero in Vulture	Potenza
Italy	U.O. di Ematologia - Centro Oncologico Basilicata	Rionero in Vulture
Italy	Ematologia - Sapienza Università di Roma	Roma
Italy	Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore	Rome
Italy	Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo
Italy	U.O. Ematologia, Azienda Ospedaliera Universitaria Senese	Siena
Italy	Ospedale	Taranto
Italy	SCDO Ematologia 2 AOU S. Giovanni Battista	Torino
Italy	Policlinico Universitario - Clinica Ematologia	Udine
Italy	Policlinico G. B. Rossi - Borgo Roma	Verona

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	Overall Survival		At one year from study entry
Secondary	Rate of complete haematologic remission t	Rate of complete haematologic remission with Nilotinib treatment and the duration of the responses.	At one year from study entry
Secondary	Nilotinib safety profile with time (grade 3-4 AE and of SAE) and causes of death		At one year from study entry
Secondary	Event Free Survival (EFS)		At one year from study entry
Secondary	Progression Free Survival (PFS)		At one year from study entry
Secondary	Rate of point mutations before or after Nilotinib treatment		At one year from study entry
Secondary	Rate of major cytogenetic response	Rate of major cytogenetic response with Nilotinib treatment and the duration of the responses.	At one year from study entry
Secondary	Rate of compete cytogenetic response	Rate of complete cytogenetic response with Nilotinib treatment and the duration of the responses.	At one year from study entry
Secondary	Rate of major molecular remission	Rate of major molecular remission with Nilotinib treatment and the duration of the responses.	At one year from study entry

External Links

•   GIMEMA Foundation Website