Acute LeukemiaReVeALNCT07831668
Real World Assessment of Venous Thromboembolic Risk in Hospitalized Patients With Acute Leukemia
An observational study of Acute Leukemia and Newly Diagnosed Acute Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Trial summary
This is a observational study designed to identify risk factors for venous thromboembolism in patients with newly diagnosed acute leukemia at the time of first admission to a Hematology Ward. Each patient will be observed for the duration of hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia, Newly Diagnosed Acute Leukemia, Thromboprophylaxis
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 study will include patients with newly diagnosed acute leukemia at the time of first admission to a Hematology Ward.
Who may be able to join
- Age equal to or greater than 18 years of age
- New diagnosis of Acute Leukemia (APL, other AML, ALL) according to the current diagnostic criteria of the ELN 2022 for myeloid lineage (AML/APL) and ELN 2024 for lymphoid lineage (ALL)
- Hospitalization in a Hematology Ward lasting at least 2 days
- Signed informed consent
Who cannot join
- Ongoing therapeutic-dose anticoagulant treatment at the time of admission (i.e., dosage exceeding standard thromboprophylactic regimens)
- Diagnosis of venous thromboembolism (VTE) or major bleeding (MB) occurring within 48 hours of hospital admission
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Real-World Assessment of Venous Thromboembolic Risk in Hospitalized Patients With Acute Leukemia (The ReVeAL Study of the GIMEMA Working Party on Hemostasis and Thrombosis)
This is a observational study designed to identify risk factors for venous thromboembolism in patients with newly diagnosed acute leukemia at the time of first admission to a Hematology Ward.
Each patient will be observed for the duration of hospitalization.
Read the detailed description
This is a prospective, observational cohort study designed to identify risk factors for venous thromboembolism (VTE) in patients with newly diagnosed acute leukemia (AL) at the time of first admission to a Hematology Ward. The study will be conducted within the GIMEMA network of Italian Hematology Centers.
The observation period for each patient will correspond to the duration of hospitalization, starting from the day of admission to the Hematology Ward, irrespective of whether antithrombotic therapy is prescribed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with venous thromboembolism event during hospitalization
Cumulative incidence of the first venous thromboembolism event from hospital admission to discharge or death
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Marietta, MD, Principal investigator, Hematology Unit AOU Modena - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831668
- Sponsor's protocol ID
- ET0226
- Acronym
- ReVeAL
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Assessment of Venous Thromboembolic Risk in Hospitalized Patients With Acute Leukemia (The ReVeAL Study of the GIMEMA Working Party on Hemostasis and Thrombosis)
- ClinicalTrials.gov ID
- NCT07831668
- Acronym / sponsor ID
- ReVeAL / ET0226
- Conditions
- Acute Leukemia, Newly Diagnosed Acute Leukemia, Thromboprophylaxis, Thromboprophylaxis in Acute Leukemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 21 Sep 2026 (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.
This is a observational study designed to identify risk factors for venous thromboembolism in patients with newly diagnosed acute leukemia at the time of first admission to a Hematology Ward.
Each patient will be observed for the duration of hospitalization.
Detailed description
This is a prospective, observational cohort study designed to identify risk factors for venous thromboembolism (VTE) in patients with newly diagnosed acute leukemia (AL) at the time of first admission to a Hematology Ward. The study will be conducted within the GIMEMA network of Italian Hematology Centers.
The observation period for each patient will correspond to the duration of hospitalization, starting from the day of admission to the Hematology Ward, irrespective of whether antithrombotic therapy is prescribed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients with newly diagnosed acute leukemia at the time of first admission to a Hematology Ward.
Key inclusion criteria (4 listed)
- Age equal to or greater than 18 years of age
- New diagnosis of Acute Leukemia (APL, other AML, ALL) according to the current diagnostic criteria of the ELN 2022 for myeloid lineage (AML/APL) and ELN 2024 for lymphoid lineage (ALL)
- Hospitalization in a Hematology Ward lasting at least 2 days
- Signed informed consent
Key exclusion criteria (2 listed)
- Ongoing therapeutic-dose anticoagulant treatment at the time of admission (i.e., dosage exceeding standard thromboprophylactic regimens)
- Diagnosis of venous thromboembolism (VTE) or major bleeding (MB) occurring within 48 hours of hospital admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with venous thromboembolism event during hospitalization
Time frame: through study completion, an average of 2 years
Cumulative incidence of the first venous thromboembolism event from hospital admission to discharge or death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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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.
Marco Marietta, MD principal investigator
Hematology Unit AOU Modena - Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia and Newly Diagnosed Acute Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (+39 0670390522, gimema@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with venous thromboembolism event during hospitalization (time frame: through study completion, an average of 2 years). 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 21 Sep 2026.