Leukemia Acute Myeloid - AMLPhase 1TOCIVENANCT07392814
Study With Tocilizumab in Combination With Venetoclax and Azacitidine Chemotherapy in Patients With Acute Myeloid Leukemia
A Phase 1 study testing increase dose of tocilizumab in people with Leukemia Acute Myeloid - AML, run by Nantes University Hospital at 1 site in France.
Trial summary
This is a phase 1, open label, interventional, single center, in patients with Acute Myeloid Leukemia (AML). This study will investigate dose escalation of tocilizumab in combination with venetoclax and azacitidine chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia Acute Myeloid - AML
- What is being tested?
- increase dose of tocilizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2026to 10 Jul 2030
- Phase
- Phase 1
- 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
Who may be able to join
- First-line AML regardless of karyotype and molecular profile
- ECOG <= 3
- Patient eligible for chemotherapy combining azacitidine and venetoclax
- Informed consent
- Liver function tests: transaminases < 3x normal, bilirubin < 1.5x normal
- Creatinine clearance > 30 ml/min
Who cannot join
- LAM3
- Patients eligible for intensive "3+7" treatment
- Uncontrolled infection
- Active and/or treated infection with Hep B, C, or HIV
- No social security or other health insurance
- Pregnant women or patients who cannot use contraception due to fertility
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- Breastfeeding women
- Minors
- Adults under guardianship, conservatorship, or legal protection
- Hypersensitivity to any of the active substances or excipients (see SPCs)
- Patients unable to understand spoken or written French
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Single-Center Phase 1 Study With Escalating Doses of Tocilizumab in Combination With Venetoclax and Azacitidine Chemotherapy in Patients With Acute Myeloid Leukemia (AML). TOCIVENA
This is a phase 1, open label, interventional, single center, in patients with Acute Myeloid Leukemia (AML). This study will investigate dose escalation of tocilizumab in combination with venetoclax and azacitidine chemotherapy.
The patient population will consist of adults men and women at least 18 years, who meet eligibility criteria. In this study propose combining tocilizumab with the standard treatment of azacitidine and venetoclax for patients with AML who are not eligible for intensive treatment.
- Conditions
- Leukemia Acute Myeloid - AML
- Being tested
- increase dose of tocilizumab
- Keywords
- Leukemia, IL6, tocilizumab
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
increase dose of tocilizumabDrug
Combining tocilizumab with the standard treatment of azacitidine and venetoclax
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Experimental | * Level 1: 4 mg/kg on Day 1 of cycles 1 to 3
* Level 2: 6 mg/kg on Day 1 of cycles 1 to 3 (starting dose for the first cohort)
* Level 3: 8 mg/kg on Day 1 of cycles 1 to 3
* Level 4: 4 mg/kg on Days 1 and 15 of cycles 1 to 3 Receives: Drug: increase dose of tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
number of DLT
Measured: 42 days
Secondary outcomes (14)
response to treatment
number of response
Measured: 28 months
response to treatment
number of response without detectable residual disease
Measured: 28 months
Death
number of days between Day 1 and Death
Measured: 48 months
follow - up
number of days between Day 1 and follow - up date
Measured: 48 months
relapse
number of days between remission day 1 and relapse
Measured: 48 months
death
number of days between remission and death
Measured: 48 months
follow up
number of days between remission and follow - up date
Measured: 48 months
relapse
number of days between remission and relapse
Measured: 48 months
relapse
number of relapse
Measured: 48 months
neutrophil
number of days of neutrophil recovery
Measured: 48 months
platelets
number of days of platelets recovery
Measured: 48 months
infection
number of infection
Measured: 48 months
cytokine
number of cytokine
Measured: 48 months
tocilizumab
number of tocilizumab
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start10 Mar 2026 (estimated)
- Primary completion10 Jul 2028 (estimated)
- Study completion10 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia Acute Myeloid - AMLStudies of the same condition, open and under way.
- More trials run by Nantes 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392814
- Sponsor's protocol ID
- RC25_0533
- Other IDs
- 2025-524725-41-00, 2025
- Acronym
- TOCIVENA
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center Phase 1 Study With Escalating Doses of Tocilizumab in Combination With Venetoclax and Azacitidine Chemotherapy in Patients With Acute Myeloid Leukemia (AML). TOCIVENA
- ClinicalTrials.gov ID
- NCT07392814
- Acronym / sponsor ID
- TOCIVENA / RC25_0533
- Conditions
- Leukemia Acute Myeloid - AML
- Keywords
- Leukemia, IL6, tocilizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- 10 Jul 2028 (estimated)
- Study completion
- 10 Jul 2030 (estimated)
- First posted
- 6 Feb 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 phase 1, open label, interventional, single center, in patients with Acute Myeloid Leukemia (AML). This study will investigate dose escalation of tocilizumab in combination with venetoclax and azacitidine chemotherapy.
The patient population will consist of adults men and women at least 18 years, who meet eligibility criteria. In this study propose combining tocilizumab with the standard treatment of azacitidine and venetoclax for patients with AML who are not eligible for intensive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Experimental | Drug: increase dose of tocilizumab* Level 1: 4 mg/kg on Day 1 of cycles 1 to 3 * Level 2: 6 mg/kg on Day 1 of cycles 1 to 3 (starting dose for the first cohort) * Level 3: 8 mg/kg on Day 1 of cycles 1 to 3 * Level 4: 4 mg/kg on Days 1 and 15 of cycles 1 to 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First-line AML regardless of karyotype and molecular profile
- ECOG <= 3
- Patient eligible for chemotherapy combining azacitidine and venetoclax
- Informed consent
- Liver function tests: transaminases < 3x normal, bilirubin < 1.5x normal
Key exclusion criteria (11 listed)
- LAM3
- Patients eligible for intensive "3+7" treatment
- Uncontrolled infection
- Active and/or treated infection with Hep B, C, or HIV
- No social security or other health insurance
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 |
|---|---|---|
| increase dose of tocilizumabCombining tocilizumab with the standard treatment of azacitidine and venetoclax | Drug | Tocilizumab |
Primary outcome
DLT
Time frame: 42 days
number of DLT
14 secondary outcomes
response to treatment
Time frame: 28 months
response to treatment
Time frame: 28 months
Death
Time frame: 48 months
follow - up
Time frame: 48 months
relapse
Time frame: 48 months
death
Time frame: 48 months
follow up
Time frame: 48 months
relapse
Time frame: 48 months
relapse
Time frame: 48 months
neutrophil
Time frame: 48 months
platelets
Time frame: 48 months
infection
Time frame: 48 months
cytokine
Time frame: 48 months
tocilizumab
Time frame: 48 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 17 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing increase dose of tocilizumab in people with Leukemia Acute Myeloid - AML, run by Nantes 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 6 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: opening soon, as of the sponsor's last update on 17 Feb 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Peterlin Pierre (02 40 08 74 018 ext. +33, pierre.peterlin@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: 42 days). 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 17 Feb 2026.