Chronic Myeloid LeukaemiaCML0609NCT01475110
Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib
An observational study of Chronic Myeloid Leukaemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 33 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukaemia
- What is being tested?
- Imatinib
- How many people
- 19 participants
- Where
- 33 sitesItaly
- Study dates
- 13 Sep 2012to 24 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients less than 18 year old.
- Use of Nilotinib as first line treatment.
- Patients treated with Nilotinib before 2005.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Italy33 sites
Ospedale
Alessandria
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria
S.G. Moscati Hospital
Avellino
Ospedale
Bari
Ospedale
Bologna
Azienda Spedali Civili
Brescia, 25100
Ospedale Ferrarotto
Catania
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
Ferrara, 44100
Policlinico di Careggi, Università delgi studi di Firenze
Florence
Clinica Ematologica - Università degli Studi
Genova
Università degli Studi
Genova
Università di Genova
Genova
ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia
Lecce, 73100
A.O. Universitaria Policlinico Martina di Messina
Messina
U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele
Milan, 20132
Federico II
Naples
Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10
Orbassano
Azienda Ospedaliera di Padova
Padova, 35128
Ospedale Cervello
Palermo, 90146
Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone
Palermo
Dipartimento Oncologico - Ospedale S.Maria delle Croci
Ravenna
Ospedale
Reggio Calabria
Ospedale
Rimini
Centro Oncologico Basilicata
Rionero in Vulture, Potenza
U.O. di Ematologia - Centro Oncologico Basilicata
Rionero in Vulture
Ematologia - Sapienza Università di Roma
Roma
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, 00168
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
Siena, 53100
Ospedale
Taranto
SCDO Ematologia 2 AOU S. Giovanni Battista
Torino
Policlinico Universitario - Clinica Ematologia
Udine, 33100
Policlinico G. B. Rossi - Borgo Roma
Verona, 37134
About this study
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
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.
Read the 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.
- Conditions
- Chronic Myeloid Leukaemia
- Being tested
- Imatinib
- Keywords
- Imatinib, Chronic Myeloid Leukaemia, Nilotinib, Adult patients, Imatinib resistant
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
Observation of Imatinib resistant patients treated with Nilotinib.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: At one year from study entry
Secondary outcomes (8)
Rate of complete haematologic remission t
Rate of complete haematologic remission with Nilotinib treatment and the duration of the responses.
Measured: At one year from study entry
Nilotinib safety profile with time (grade 3-4 AE and of SAE) and causes of death
Measured: At one year from study entry
Event Free Survival (EFS)
Measured: At one year from study entry
Progression Free Survival (PFS)
Measured: At one year from study entry
Rate of point mutations before or after Nilotinib treatment
Measured: At one year from study entry
Rate of major cytogenetic response
Rate of major cytogenetic response with Nilotinib treatment and the duration of the responses.
Measured: At one year from study entry
Rate of compete cytogenetic response
Rate of complete cytogenetic response with Nilotinib treatment and the duration of the responses.
Measured: At one year from study entry
Rate of major molecular remission
Rate of major molecular remission with Nilotinib treatment and the duration of the responses.
Measured: At one year from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study start13 Sep 2012
- Primary completion24 Nov 2016
- Study completion24 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe SAGLIO, Pr., Principal investigator, Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475110
- Sponsor's protocol ID
- CML0609
- Acronym
- CML0609
- Status last verified
- Oct 2022
- First submitted
- 11 Nov 2011
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01475110
- Acronym / sponsor ID
- CML0609 / CML0609
- Conditions
- Chronic Myeloid Leukaemia
- Keywords
- Imatinib, Chronic Myeloid Leukaemia, Nilotinib, Adult patients, Imatinib resistant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 13 Sep 2012 (actual)
- Primary completion
- 24 Nov 2016 (actual)
- Study completion
- 24 Nov 2016 (actual)
- First posted
- 21 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort group | – | Drug: ImatinibAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients less than 18 year old.
- Use of Nilotinib as first line treatment.
- Patients treated with Nilotinib before 2005.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImatinibObservation of Imatinib resistant patients treated with Nilotinib. | Drug | Study cohort group |
Primary outcome
Overall Survival
Time frame: At one year from study entry
8 secondary outcomes
Rate of complete haematologic remission t
Time frame: At one year from study entry
Nilotinib safety profile with time (grade 3-4 AE and of SAE) and causes of death
Time frame: At one year from study entry
Event Free Survival (EFS)
Time frame: At one year from study entry
Progression Free Survival (PFS)
Time frame: At one year from study entry
Rate of point mutations before or after Nilotinib treatment
Time frame: At one year from study entry
Rate of major cytogenetic response
Time frame: At one year from study entry
Rate of compete cytogenetic response
Time frame: At one year from study entry
Rate of major molecular remission
Time frame: At one year from study entry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- GIMEMA Foundation WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe SAGLIO, Pr. principal investigator
Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukaemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 33 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: At one year from study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.