CancerNCT06251648
Acute Lymphoblastic Leukaemia Related to Lenalidomide (LenALL)
An observational study of Cancer, run by University Hospital, Caen at 1 site in France.
Trial summary
Although lenalidomide (LEN) have proved effective in treating many cancers, few patients receiving LEN may experience rare but life-threatening adverse events such as Acute Lymphoblastic Leukaemia (ALL). Today, data about ALL are scarce. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Lenalidomide
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2024to 31 Mar 2024
- 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: Cancer patients treated with LEN and experiencing ALL
Who may be able to join
- Case reported in the World Health Organization (WHO, also called VigiBase) at the time of the extraction
- Patients treated with at least LEN (L04AX04)
Who cannot join
- -Chronology not compatible between LEN and ALL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Lymphoblastic Leukaemia Related to Lenalidomide in Patients With Cancer: an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database
Although lenalidomide (LEN) have proved effective in treating many cancers, few patients receiving LEN may experience rare but life-threatening adverse events such as Acute Lymphoblastic Leukaemia (ALL). Today, data about ALL are scarce.
The objective was to investigate reports of ALL adverse events related to LEN in patients with cancer using the World Health Organization (WHO) pharmacovigilance database.
- Conditions
- Cancer
- Being tested
- Lenalidomide
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Patients exposed to LEN
What is being measured
The primary outcome is the main question the study is designed to answer.
ALL reports related to LEN (from WHO database).
Identification of the ALL adverse events related to LEN reported in the World Health Organization (WHO) database of individual safety case reports.
Measured: From inception to February, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion15 Feb 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre-Marie MORICE, PharmD, PhD, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251648
- Sponsor's protocol ID
- LenALL#01-02-2024
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Lymphoblastic Leukaemia Related to Lenalidomide in Patients With Cancer: an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database
- ClinicalTrials.gov ID
- NCT06251648
- Acronym / sponsor ID
- LenALL#01-02-2024
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 9 Feb 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.
Although lenalidomide (LEN) have proved effective in treating many cancers, few patients receiving LEN may experience rare but life-threatening adverse events such as Acute Lymphoblastic Leukaemia (ALL). Today, data about ALL are scarce.
The objective was to investigate reports of ALL adverse events related to LEN in patients with cancer using the World Health Organization (WHO) pharmacovigilance database.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients treated with LEN and experiencing ALL
Key inclusion criteria (2 listed)
- Case reported in the World Health Organization (WHO, also called VigiBase) at the time of the extraction
- Patients treated with at least LEN (L04AX04)
Key exclusion criteria (1 listed)
- -Chronology not compatible between LEN and ALL
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 |
|---|---|---|
| LenalidomidePatients exposed to LEN | Drug | – |
Primary outcome
ALL reports related to LEN (from WHO database).
Time frame: From inception to February, 2024
Identification of the ALL adverse events related to LEN reported in the World Health Organization (WHO) database of individual safety case reports.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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 Cancer, run by University Hospital, Caen 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 2 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 9 Feb 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?
ALL reports related to LEN (from WHO database). (time frame: From inception to February, 2024). 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 9 Feb 2024.