Chronic Myeloid Leukemia (CML)K2SPIRITNCT06646978
Long-term Risk of Second Primary Malignancies for Chronic Myeloid Leukaemia in the French Imatinib-based SPIRIT Trial
An observational study of Chronic Myeloid Leukemia (CML), run by Poitiers University Hospital at 1 site in France.
Trial summary
Imatinib is a tyrosine kinase inhibitor that has improved the prognosis of patients with chronic myeloid leukemia (CML). CML has become a chronic disease requiring long-term administration of imatinib. Late adverse effects were initially unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia (CML)
- What is being tested?
- Imatinib (STI571)
- How many people
- 787 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2024to May 2025
- 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: All patients with chronic myeloid leukaemia included in the French imatinib-based SPIRIT trial
Who may be able to join
- Included in the French SPIRIT trial
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Imatinib is a tyrosine kinase inhibitor that has improved the prognosis of patients with chronic myeloid leukemia (CML). CML has become a chronic disease requiring long-term administration of imatinib. Late adverse effects were initially unknown. Since 2005, imatinib has been suspected to increase the risk of second primary malignancies (SPM). Through the French "STI571 Prospective Randomized Trial" (SPIRIT), we studied the incidence of SPM after more than 20 years of exposure, and treatment strategies for CML and SPM at their occurrence.
- Conditions
- Chronic Myeloid Leukemia (CML)
- Being tested
- Imatinib (STI571)
- Keywords
- second primary malignancies, imatinib
- 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.
Imatinib (STI571)Drug
Imatinib-based regimen
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic myeloid leukaemia included in the French imatinib-based SPIRIT trial | Not described Receives: Drug: Imatinib (STI571) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of second primary malignancies (SPM)
SPM is an invasive primary cancer diagnosed at least 6 months after CML diagnosis. Non-melanoma skin cancers were excluded from the analysis.
Measured: Through study completion, an average of 20 years
Secondary outcomes (1)
Treatment strategies for CML and SPM at their occurrence
For treatment strategy of CML: response, modification of treatment (temporary discontinuation, permanent interruption, replace by a new generation TKI), relapse.
For treatment strategy of SPM: intent of treatment (curative, palliative, follow without treatment), type of treatment (surgery, radiotherapy, chemotherapy, targeted therapy), atypical adverses events, modification of treatment.
Measured: At the occurence of SPM. Through study completion, on average 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 May 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid Leukemia (CML)Studies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 787 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646978
- Sponsor's protocol ID
- K2SPIRIT
- Acronym
- K2SPIRIT
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Preudhomme C, Guilhot J, Nicolini FE, Guerci-Bresler A, Rigal-Huguet F, Maloisel F, Coiteux V, Gardembas M, Berthou C, Vekhoff A, Rea D, Jourdan E, Allard C, Delmer A, Rousselot P, Legros L, Berger M, Corm S, Etienne G, Roche-Lestienne C, Eclache V, Mahon FX, Guilhot F; SPIRIT Investigators; France Intergroupe des Leucemies Myeloides Chroniques (Fi-LMC). Imatinib plus peginterferon alfa-2a in chronic myeloid leukemia. N Engl J Med. 2010 Dec 23;363(26):2511-21. doi: 10.1056/NEJMoa1004095.
PubMed 21175313
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Risk of Second Primary Malignancies for Chronic Myeloid Leukaemia in the French Imatinib-based SPIRIT Trial
- ClinicalTrials.gov ID
- NCT06646978
- Acronym / sponsor ID
- K2SPIRIT / K2SPIRIT
- Conditions
- Chronic Myeloid Leukemia (CML)
- Keywords
- second primary malignancies, imatinib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 787 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 17 Oct 2024 (actual)
- 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.
Imatinib is a tyrosine kinase inhibitor that has improved the prognosis of patients with chronic myeloid leukemia (CML). CML has become a chronic disease requiring long-term administration of imatinib. Late adverse effects were initially unknown. Since 2005, imatinib has been suspected to increase the risk of second primary malignancies (SPM). Through the French "STI571 Prospective Randomized Trial" (SPIRIT), we studied the incidence of SPM after more than 20 years of exposure, and treatment strategies for CML and SPM at their occurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic myeloid leukaemia included in the French imatinib-based SPIRIT trial | – | Drug: Imatinib (STI571) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with chronic myeloid leukaemia included in the French imatinib-based SPIRIT trial
Key inclusion criteria (1 listed)
- Included in the French SPIRIT trial
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Imatinib (STI571)Imatinib-based regimen | Drug | Patients with chronic myeloid leukaemia included in the French imatinib-based SPIRIT trial |
Primary outcome
Risk of second primary malignancies (SPM)
Time frame: Through study completion, an average of 20 years
SPM is an invasive primary cancer diagnosed at least 6 months after CML diagnosis. Non-melanoma skin cancers were excluded from the analysis.
1 secondary outcome
Treatment strategies for CML and SPM at their occurrence
Time frame: At the occurence of SPM. Through study completion, on average 20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Background: PubMed 21175313Preudhomme C, Guilhot J, Nicolini FE, Guerci-Bresler A, Rigal-Huguet F, Maloisel F, Coiteux V, Gardembas M, Berthou C, Vekhoff A, Rea D, Jourdan E, Allard C, Delmer A, Rousselot P, Legros L, Berger M, Corm S, Etienne G, Roche-Lestienne C, Eclache V, Mahon FX, Guilhot F; SPIRIT Investigators; France Intergroupe des Leucemies Myeloides Chroniques (Fi-LMC). Imatinib plus peginterferon alfa-2a in chronic myeloid leukemia. N Engl J Med. 2010 Dec 23;363(26):2511-21. doi: 10.1056/NEJMoa1004095.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Leukemia (CML), run by Poitiers University Hospital at 1 site in France.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
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?
Risk of second primary malignancies (SPM) (time frame: Through study completion, an average of 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06646978, which also lists 1 linked publication.
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 17 Oct 2024.