Adult Acute Myeloid LeukemiaNCT06045819
Relation Between Venetoclax Plasma Concentration and Remission in Adults with Acute Myeloid Leukemia (PREDICLAX)
An observational study of Adult Acute Myeloid Leukemia, run by University Hospital, Caen at 1 site in France.
Trial summary
Background: In combination with hypomethylating drugs, venetoclax has recently changed the therapeutic management of patients with newly diagnosed acute myeloid leukemia (AML) for whom standard induction chemotherapy was not an option. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Adult Acute Myeloid Leukemia
- What is being tested?
- Blood sampling for venetoclax drug dosage (venous puncture)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2024to Jan 2026
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients with untreated AML and ineligible for standard cytarabine and anthracycline induction therapy
Who may be able to join
- Subject must have a confirmed diagnosis of previously untreated AML (ELN 2022 criteria) within 28 days of the onset of symptoms. Only previous cytoreductive treatments (e.g. hydroxyurea) are authorized.
- Subject must be ineligible for standard cytarabine and anthracycline induction therapy according to the following criteria:
- Subject aged ≥ 75 years.
- OR subject aged between 60 and 74 with at least one of the following comorbidities:
- ECOG performance status: of 2 or 3.
- cardiac history: heart failure requiring treatment, left ventricular ejection fraction ≤ 50%, chronic stable angina.
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- carbon monoxide diffusion capacity ≤ 65% or forced expiratory volume in one second ≤ 65%.
- creatinine clearance between 30 and 45 mL/min/m².
- liver damage (not related to AML) with total bilirubin between 1.5 and 3 × upper normal limit.
- any other comorbidity deemed by the physician to be incompatible with standard induction chemotherapy.
- Patients are eligible for the recommended standard treatment, i.e. a combination of venetoclax and a hypomethylating agent.
- Subjects must voluntarily sign and date an informed consent form authorized by the relevant authorities.
- The participation of the subject in another interventional study not interfering with the pathophysiological, pharmacological and clinical rationale of this protocol is possible.
Who cannot join
- blood leukocytes >25 G/L.
- Subject has already received anticancer treatment (drugs, surgery, radiotherapy) for AML, hematological malignancy or malignant cancer (within the last 2 years).
- Subjects with AML with central nervous system involvement or promyelocytic type (AML-M3).
- Subject to an uncontrolled intercurrent disease such as:
- infection (viral, bacterial or fungal) requiring treatment;
- symptomatic congestive heart failure;
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- unstable angina pectoris
- cardiac arrhythmia
- psychiatric illness or drug addiction that would limit compliance with study requirements (risk of treatment non-adherence or low venous capital).
- Documented hypersensitivity to the drugs used to treat the subject.
- Subject has been exposed to potent CYP450 inducers or inhibitors (including grapefruit, Seville oranges) within 7 days prior to treatment initiation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Caen
Caen, 14000
Sylvain Chantepie, MD
About this study
Official title: Study of the Association Between Residual Venetoclax Plasma Concentration and Composite Complete Remission in Adults with Newly Diagnosed Acute Myeloid Leukemia Ineligible for Intensive Chemotherapy (PREDICLAX)
Background: In combination with hypomethylating drugs, venetoclax has recently changed the therapeutic management of patients with newly diagnosed acute myeloid leukemia (AML) for whom standard induction chemotherapy was not an option. Over and above the clinical benefits of this combination, the data show that more than half the patients did not show remission criteria, even after the first month's exposure to venetoclax.
Hypothesis: To compare the mean residual venetoclax plasma concentrations obtained in patients who went into complete composite remission versus those who did not go into remission at the end of the first cycle of venetoclax + azacitidine treatment.
Method: According to the French law, this is a multicenter, non-comparative, open-label, single-arm, interventional study with minimal risks and constraints. Selection, information and inclusion will concern adult patients (≥60 years) with a confirmed diagnosis of AML according to ELN 2022 guidelines. Included patients will be treated as standard care with a combination of venetoclax+azacitidine. This research protocol will not modify their usual care.
- Conditions
- Adult Acute Myeloid Leukemia
- Being tested
- Blood sampling for venetoclax drug dosage (venous puncture)
- 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.
Blood sampling for venetoclax drug dosage (venous puncture)Biological
Also called Biological: Capillary Blood sampling for venetoclax drug dosage with Volumetric Absorptive Microsampling (VAMS™) technology with Mitra® device (CE-IVD /IVDR), Biological: Blood sampling for azole antifungal drug dosage (venous puncture)
8 blood samples for venetoclax and azole antifungal drugs identification and dosage will be taken by venous and capillary punctures throughout management of patients
| Study group | Role | What they receive |
|---|---|---|
| Patients with composite complete remission | Patients in composite complete remission following the first cycle of venetoclax (400 mg/day, orally, after a ramp-up phase of the first 3 days) + azacytidine (75mg/m²,intravenous, at the start of each cycle from day 1 to day 7) Receives: Biological: Blood sampling for venetoclax drug dosage (venous puncture) | |
| Patients without composite complete remission | Patients not in composite complete remission following the first cycle of venetoclax (400 mg/day, orally, after a ramp-up phase of the first 3 days) + azacytidine (75mg/m²,intravenous, at the start of each cycle from day 1 to day 7) Receives: Biological: Blood sampling for venetoclax drug dosage (venous puncture) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of mean plasma residual concentration of venetoclax
To compare the mean plasma residual concentration (ng/mL) of venetoclax (determined by LC-MS-MS) between patients who have entered composite complete remission (defined by the presence of remission criteria ≥ CRi, according to ELN 2022 guidelines) versus those who have not at the end of the first cycle of venetoclax+azacitidine treatment.
Measured: 1 month
Secondary outcomes (7)
Study relationship between mean plasma residual concentration of venetoclax and remission occurrence
To estimate mean residual plasma concentrations (Cres, ng/mL) of venetoclax and azole antifungals during patients' usual care. Then study the relationship between mean venetoclax Cres and the achievement (or non-achievement) of remission over time (according to ELN 2022 guidelines) .
Measured: 24 months
Study performance of mean venetoclax Cres
To evaluate the performance (ROC curve) of mean venetoclax Cres (ng/mL) as a predictive biomarker of event-free survival (EFS) at 6 and 12 months.
Measured: 6 and 12 months
Study survival
To estimate event-free survival (EFS), relapse-free survival (RFS) and overall survival (OS).
Measured: 24 months
Study early deaths
To estimate the proportion of early deaths at 30 and 60 days post-inclusion.
Measured: 24 months
Study the variability of plasma venetoclax and antifungal concentrations over time
To estimate the inter-individual (IIV) and intra-individual (IOV) variability of plasma venetoclax and antifungal concentrations over time.
Measured: 24 months
Study the impact of parameters in uni- and multivariate analyses.
To estimate the impact of the following parameters to the diagnosis of remission or Cres (venetoclax):
- patient characteristics: age [years], BMI ([kg/m²], sex[male vs female], ECOG [1,2 or 3], comorbidities reported in inclusion criteria, number of cytopenia grade>2, according to CTCAE v5, white blood cell count [G/L], creatininemia [µmol/L], cytoreduction (yes or not).
- disease: AML classification (ELN 2022 guidelines), blast counts (G/L), cytogenetic status (fail, normal or not) and report, genetic status and report, abnormal rearrangement of genetic material and report.
- and (co-)treatments of interest: fluconazole, isavuconazole, itraconazole, posaconazole, voriconazole, cannabidiol, ciclosporine, clarithromycine, diltiazem, ritonavir, verapamil,milk thistle, licorice; bosentan, carbamazépine, efavirenz, enzalutamide, felbamate, phénytoïne, phénobarbital, rifampicine, St. John's wort, grapefruit, bitter orange, star fruit).
Measured: 24 months
Study adverse events of interest
To compare mean venetoclax Cres between patients who have experienced one or more of the 5 AEs of interest versus those who have not over time.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start8 Apr 2024
- Primary completionFeb 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Acute Myeloid LeukemiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Marie Morice, PharmD, PhD, Principal investigator, University Teaching Hospital of CaenSylvain Chantepie, MD, Principal investigator, University Teaching Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045819
- Sponsor's protocol ID
- 2023-A01909-36
- Status last verified
- Feb 2025
- First submitted
- 4 Sep 2023
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Association Between Residual Venetoclax Plasma Concentration and Composite Complete Remission in Adults with Newly Diagnosed Acute Myeloid Leukemia Ineligible for Intensive Chemotherapy (PREDICLAX)
- ClinicalTrials.gov ID
- NCT06045819
- Acronym / sponsor ID
- 2023-A01909-36
- Conditions
- Adult Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 21 Sep 2023 (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.
Background: In combination with hypomethylating drugs, venetoclax has recently changed the therapeutic management of patients with newly diagnosed acute myeloid leukemia (AML) for whom standard induction chemotherapy was not an option. Over and above the clinical benefits of this combination, the data show that more than half the patients did not show remission criteria, even after the first month's exposure to venetoclax.
Hypothesis: To compare the mean residual venetoclax plasma concentrations obtained in patients who went into complete composite remission versus those who did not go into remission at the end of the first cycle of venetoclax + azacitidine treatment.
Method: According to the French law, this is a multicenter, non-comparative, open-label, single-arm, interventional study with minimal risks and constraints. Selection, information and inclusion will concern adult patients (≥60 years) with a confirmed diagnosis of AML according to ELN 2022 guidelines. Included patients will be treated as standard care with a combination of venetoclax+azacitidine. This research protocol will not modify their usual care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with composite complete remission | – | Biological: Blood sampling for venetoclax drug dosage (venous puncture)Patients in composite complete remission following the first cycle of venetoclax (400 mg/day, orally, after a ramp-up phase of the first 3 days) + azacytidine (75mg/m²,intravenous, at the start of each cycle from day 1 to day 7) |
| Patients without composite complete remission | – | Biological: Blood sampling for venetoclax drug dosage (venous puncture)Patients not in composite complete remission following the first cycle of venetoclax (400 mg/day, orally, after a ramp-up phase of the first 3 days) + azacytidine (75mg/m²,intravenous, at the start of each cycle from day 1 to day 7) |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with untreated AML and ineligible for standard cytarabine and anthracycline induction therapy
Key inclusion criteria (13 listed)
- Subject must have a confirmed diagnosis of previously untreated AML (ELN 2022 criteria) within 28 days of the onset of symptoms. Only previous cytoreductive treatments (e.g. hydroxyurea) are authorized.
- Subject must be ineligible for standard cytarabine and anthracycline induction therapy according to the following criteria:
- Patients are eligible for the recommended standard treatment, i.e. a combination of venetoclax and a hypomethylating agent.
- Subjects must voluntarily sign and date an informed consent form authorized by the relevant authorities.
- The participation of the subject in another interventional study not interfering with the pathophysiological, pharmacological and clinical rationale of this protocol is possible.
Key exclusion criteria (11 listed)
- blood leukocytes >25 G/L.
- Subject has already received anticancer treatment (drugs, surgery, radiotherapy) for AML, hematological malignancy or malignant cancer (within the last 2 years).
- Subjects with AML with central nervous system involvement or promyelocytic type (AML-M3).
- Subject to an uncontrolled intercurrent disease such as:
- Documented hypersensitivity to the drugs used to treat the subject.
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 |
|---|---|---|
| Blood sampling for venetoclax drug dosage (venous puncture)Also: Biological: Capillary Blood sampling for venetoclax drug dosage with Volumetric Absorptive Microsampling (VAMS™) technology with Mitra® device (CE-IVD /IVDR), Biological: Blood sampling for azole antifungal drug dosage (venous puncture)8 blood samples for venetoclax and azole antifungal drugs identification and dosage will be taken by venous and capillary punctures throughout management of patients | Biological | Patients with composite complete remission, Patients without composite complete remission |
Primary outcome
Comparison of mean plasma residual concentration of venetoclax
Time frame: 1 month
To compare the mean plasma residual concentration (ng/mL) of venetoclax (determined by LC-MS-MS) between patients who have entered composite complete remission (defined by the presence of remission criteria ≥ CRi, according to ELN 2022 guidelines) versus those who have not at the end of the first cycle of venetoclax+azacitidine treatment.
7 secondary outcomes
Study relationship between mean plasma residual concentration of venetoclax and remission occurrence
Time frame: 24 months
Study performance of mean venetoclax Cres
Time frame: 6 and 12 months
Study survival
Time frame: 24 months
Study early deaths
Time frame: 24 months
Study the variability of plasma venetoclax and antifungal concentrations over time
Time frame: 24 months
Study the impact of parameters in uni- and multivariate analyses.
Time frame: 24 months
Study adverse events of interest
Time frame: 24 months
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 28 Feb 2025.
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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.
Pierre-Marie Morice, PharmD, PhD principal investigator
University Teaching Hospital of Caen
Sylvain Chantepie, MD principal investigator
University Teaching Hospital of Caen
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 Adult Acute Myeloid Leukemia, 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 13 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 28 Feb 2025. 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?
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 Sylvain Chantepie, MD (+33231272107, chantepie-s@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of mean plasma residual concentration of venetoclax (time frame: 1 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 28 Feb 2025.