Observational Study in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia (CML) Treated With Nilotinib: Follow-up of the Italian Patients (CML0609)
This study is currently recruiting participants.
Verified February 2012 by Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01475110
First received: November 11, 2011
Last updated: February 10, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Myeloid Leukaemia |
Drug: Imatinib |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Primary Outcome Measures:
- Overall Survival [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rate of complete haematologic remission t [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]Rate of complete haematologic remission with Nilotinib treatment and the duration of the responses.
- Nilotinib safety profile with time (grade 3-4 AE and of SAE) and causes of death [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]
- Event Free Survival (EFS) [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]
- Progression Free Survival (PFS) [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]
- Rate of point mutations before or after Nilotinib treatment [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]
- Rate of major cytogenetic response [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]Rate of major cytogenetic response with Nilotinib treatment and the duration of the responses.
- Rate of compete cytogenetic response [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]Rate of complete cytogenetic response with Nilotinib treatment and the duration of the responses.
- Rate of major molecular remission [ Time Frame: At one year from study entry ] [ Designated as safety issue: No ]Rate of major molecular remission with Nilotinib treatment and the duration of the responses.
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Study cohort group
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. |
Drug: Imatinib
Observation of Imatinib resistant patients treated with Nilotinib.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
The GIMEMA CML Working Party promotes an observational (retrospective and perspective) study of Imatinib-resistant or intolerant CML patients treated with Nilotinib in Italy. Enrollement will include all patients who started Nilotinib between January 2005 and December 2012.
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475110
Contacts
| Contact: Paola FAZI, Dr. | p.fazi@gimema.it | |
| Contact: Enrico CREA | e.crea@gimema.it |
Locations
| Italy | |
| Centro Oncologico Basilicata | Not yet recruiting |
| Rionero in Vulture, Potenza, Italy | |
| Contact: Pellegrino Musto, MD, PhD | |
| Principal Investigator: Pellegrino MUSTO, Pr. | |
| Azienda Spedali Civili | Not yet recruiting |
| Brescia, Italy, 25100 | |
| Contact: Domenico RUSSO | |
| Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna | Not yet recruiting |
| Ferrara, Italy, 44100 | |
| Contact: Antonio CUNEO, Pr. | |
| Principal Investigator: Antonio CUNEO, Pr. | |
| Sub-Investigator: Gian Matteo Rigolin, Dr. | |
| Policlinico di Careggi, Università delgi studi di Firenze | Not yet recruiting |
| Firenze, Italy | |
| Contact: Alberto BOSI | |
| Principal Investigator: Alberto BOSI, Dr. | |
| Sub-Investigator: Giacomo GIANFALDONI, Dr. | |
| Clinica Ematologica - Università degli Studi | Not yet recruiting |
| Genova, Italy | |
| Contact: Angelo Michele CARELLA, Pr. | |
| Principal Investigator: Angelo Michele CARELLA, Pr. | |
| ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia | Not yet recruiting |
| Lecce, Italy, 73100 | |
| Contact: Nicola DI RENZO | |
| Principal Investigator: Nicola DI RENZO, Dr. | |
| Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10 | Recruiting |
| Orbassano, Italy | |
| Contact: Giuseppe Saglio, Pr | |
| Azienda Ospedaliera di Padova | Not yet recruiting |
| Padova, Italy, 35128 | |
| Contact: Gianpietro C. Semenzato, MD 39-049-821-2298 g.semenzato@unipd.it | |
| Policlinico G. B. Rossi - Borgo Roma | Not yet recruiting |
| Verona, Italy, 37134 | |
| Contact: Giovanni Pizzolo, MD giovanni.pizzolo@univr.it | |
| Principal Investigator: Giovanni PIZZOLO, Pr. | |
| Sub-Investigator: Dino DE VENERI, Dr. | |
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
| Principal Investigator: | Giuseppe SAGLIO, Pr. | Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| ClinicalTrials.gov Identifier: | NCT01475110 History of Changes |
| Other Study ID Numbers: | CML0609 |
| Study First Received: | November 11, 2011 |
| Last Updated: | February 10, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
|
Imatinib Chronic Myeloid Leukaemia Nilotinib Adult patients Imatinib resistant |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |
Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013