Acute Myeloid LeukemiaNCT07343687
Clinico-hematological and Coagulation Profiles in Newly Diagnosed Acute Myeloid Leukemia Patients Treated With Intensive Induction Chemotherapy .
An observational study of Acute Myeloid Leukemia, run by Assiut University.
Trial summary
Acute myeloid leukemia (AML) is a heterogeneous hematological malignancy characterized by clonal proliferation of myeloid precursors in the bone marrow, leading to impaired hematopoiesis and bone marrow failure[1,2]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Mar 2027
- 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: Newly diagnosed AML patients (age ≥18).
Who may be able to join
- Newly diagnosed AML patients (age ≥18).
- Undergoing intensive induction therapy (Idarubicin 12 mg/m2 per day for 2-3 days , and cyarabine 100mg /day For 5-7 days ).
Who cannot join
- * AML (M3).
- Relapsed patients with AML.
- patients with AML who started chemotherapy before enrollment in the study.
- AML with antecedent hematologic malignancy ,or solid tumors.
- Abnormal liver function tests, known liver disease.
- Pregnancy.
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- Chronic kidney disease : moderate to severe stage.
- Prior anticoagulant use.
- Active infection/sepsis on admission.
- DIC from other causes.
About this study
Acute myeloid leukemia (AML) is a heterogeneous hematological malignancy characterized by clonal proliferation of myeloid precursors in the bone marrow, leading to impaired hematopoiesis and bone marrow failure[1,2]. Which results in ineffective erythropoiesis and megakaryopoiesis , clinically manifesting as relatively rapid bone marrow failure compared to chronic and indolent leukemias. This lead to inadequate production of red blood cells and platelets. Patients with AML frequently present with cytopenias, including thrombocytopenia, which significantly increases the risk of bleeding complications. Bleeding is a major clinical concern in AML, with studies reporting that 40-70% of patients experience bleeding manifestations at diagnosis[3,4].
Disseminated intravascular coagulation is a particularly significant complication in AML, occurring in 10-40% of patients at presentation. The presence of overt DIC at diagnosis has been shown to be a strong predictor of both bleeding and thrombotic events, as well as early mortality in AML patients[7,8]. The pathogenesis of DIC in AML is thought to involve the release of tissue factor-like material and cytokines from leukemic blasts, which activate the coagulation cascade and lead to widespread fibrin formation and consumption of clotting factors. This consumptive coagulopathy results in a paradoxical state where patients are at risk for both thrombosis and severe bleeding[7,8].
Read more
In addition to DIC, primary hemostatic defects have been identified as important contributors to bleeding risk in AML. Studies have demonstrated that von Willebrand factor (vWF) activity, specifically vWF ristocetin cofactor activity (vWF:RCo), is significantly reduced in AML patients at diagnosis and correlates with the severity of bleeding manifestations[9,10]. Lower vWF:RCo activity has been observed in patients with major bleeding episodes, suggesting its potential as a prognostic marker for bleeding risk independent of other laboratory parameters. Furthermore, alterations in factor VIII activity and other components of the coagulation cascade have been implicated in the pathogenesis of bleeding in AML[9,10].
Treatment options vary depending on patient-specific factors, and hematopoietic stem cell transplant remains the only curative therapy. Although the administration of multi-agent induction chemotherapy can achieve complete remission , allogeneic stem cell transplantation is the only established curative therapy. Despite advancements in therapeutic approaches, prognosis remains suboptimal , specially among the older populations.[15,16,17].
Laboratory evaluation of coagulation profiles in AML typically includes assessment of prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen levels, and D-dimer, which help to identify and monitor coagulopathy and fibrinolysis. Studies have shown significant differences in PT between acute and chronic leukemia patients, highlighting the importance of coagulation testing in the acute setting. The International Society on Thrombosis and Haemostasis (ISTH) DIC score has emerged as a valuable tool for predicting early mortality and guiding clinical management in AML patients with coagulopathy[11,12].
- Conditions
- Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | Newly diagnosed AML patients (age ≥18) Undergoing intensive induction therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
coagulation profile abnormalities
difference in coagulation profile abnormalities in Newly diagnosed AML patients before and after treatment with intensive Induction chemotherapy.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mostafa Mahmoud Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343687
- Sponsor's protocol ID
- clinicohematological AML
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinico-hematological and Coagulation Profiles in Newly Diagnosed Acute Myeloid Leukemia Patients Treated With Intensive Induction Chemotherapy .
- ClinicalTrials.gov ID
- NCT07343687
- Acronym / sponsor ID
- clinicohematological AML
- Conditions
- Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Jan 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.
Acute myeloid leukemia (AML) is a heterogeneous hematological malignancy characterized by clonal proliferation of myeloid precursors in the bone marrow, leading to impaired hematopoiesis and bone marrow failure[1,2]. Which results in ineffective erythropoiesis and megakaryopoiesis , clinically manifesting as relatively rapid bone marrow failure compared to chronic and indolent leukemias. This lead to inadequate production of red blood cells and platelets. Patients with AML frequently present with cytopenias, including thrombocytopenia, which significantly increases the risk of bleeding complications. Bleeding is a major clinical concern in AML, with studies reporting that 40-70% of patients experience bleeding manifestations at diagnosis[3,4].
Disseminated intravascular coagulation is a particularly significant complication in AML, occurring in 10-40% of patients at presentation. The presence of overt DIC at diagnosis has been shown to be a strong predictor of both bleeding and thrombotic events, as well as early mortality in AML patients[7,8]. The pathogenesis of DIC in AML is thought to involve the release of tissue factor-like material and cytokines from leukemic blasts, which activate the coagulation cascade and lead to widespread fibrin formation and consumption of clotting factors. This consumptive coagulopathy results in a paradoxical state where patients are at risk for both thrombosis and severe bleeding[7,8].
In addition to DIC, primary hemostatic defects have been identified as important contributors to bleeding risk in AML. Studies have demonstrated that von Willebrand factor (vWF) activity, specifically vWF ristocetin cofactor activity (vWF:RCo), is significantly reduced in AML patients at diagnosis and correlates with the severity of bleeding manifestations[9,10]. Lower vWF:RCo activity has been observed in patients with major bleeding episodes, suggesting its potential as a prognostic marker for bleeding risk independent of other laboratory parameters. Furthermore, alterations in factor VIII activity and other components of the coagulation cascade have been implicated in the pathogenesis of bleeding in AML[9,10].
Treatment options vary depending on patient-specific factors, and hematopoietic stem cell transplant remains the only curative therapy. Although the administration of multi-agent induction chemotherapy can achieve complete remission , allogeneic stem cell transplantation is the only established curative therapy. Despite advancements in therapeutic approaches, prognosis remains suboptimal , specially among the older populations.[15,16,17].
Laboratory evaluation of coagulation profiles in AML typically includes assessment of prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen levels, and D-dimer, which help to identify and monitor coagulopathy and fibrinolysis. Studies have shown significant differences in PT between acute and chronic leukemia patients, highlighting the importance of coagulation testing in the acute setting. The International Society on Thrombosis and Haemostasis (ISTH) DIC score has emerged as a valuable tool for predicting early mortality and guiding clinical management in AML patients with coagulopathy[11,12].
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –Newly diagnosed AML patients (age ≥18) Undergoing intensive induction therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed AML patients (age ≥18).
Key inclusion criteria (2 listed)
- Newly diagnosed AML patients (age ≥18).
- Undergoing intensive induction therapy (Idarubicin 12 mg/m2 per day for 2-3 days , and cyarabine 100mg /day For 5-7 days ).
Key exclusion criteria (10 listed)
- * AML (M3).
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
coagulation profile abnormalities
Time frame: 3 month
difference in coagulation profile abnormalities in Newly diagnosed AML patients before and after treatment with intensive Induction chemotherapy.
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 15 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Assiut University.
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 10 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 15 Jan 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?
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?
coagulation profile abnormalities (time frame: 3 month). 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 15 Jan 2026.