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Can an Anti-Inflammation drug make AML chemotherapy work better?

NCT ID NCT04547062

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether adding tocilizumab, a drug that blocks an inflammation signal called IL-6, to standard chemotherapy helps adults with high-risk acute myeloid leukemia. Participants receive idarubicin and cytarabine, the usual induction chemotherapy, plus a single dose of tocilizumab on day 8. The phase 1 study enrolls about 12 people and mainly checks safety and the highest dose that does not cause serious side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tocilizumab, an anti-IL6 drug, added to standard chemotherapy
What this could lead to
If it works, this could point toward a way to improve chemotherapy outcomes for people whose AML has a poor prognosis.
What could go wrong
This is a small phase 1 safety study, so the main goal is finding a safe dose, not proving the combination works. The drug may add side effects or fail to improve remission rates.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

12 people

The number who actually took part.

Started

Dec 2020

Finished

Apr 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- AML with a poor prognosis defined according to the criteria below: LAM First line: Age \<60 years and unfavorable risk according to the 2017 ELN Age\> = 60 years old and intermediate or unfavorable risk according to the ELN 2017 LAM in Relapse: whatever the age * ECOG \<= 2 * Patient eligible for intensive chemotherapy * Informed consent * Liver function tests: transaminases \<3x normal, bilirubin \<1.5X normal * Creatinine clearance\> 60ml / min * LVEF\> = 50% Exclusion Criteria: * Uncontrolled infection * Hep B, C, HIV + * History of diverticulosis / diverticulitis * No social security or any other scheme * Pregnant women or patient unable to take contraception(contraceptive pill, abstinence, IUD unauthorized) in case of fertility. A patient who cannot continue contraception for at least 3 months after the last injection of TOCILIZUMAB is not eligible. * Lactating women * Minors * Adults under guardianship, curatorship or legal protection * Hypersensitivity to one of the active substances or to one of the excipients * Patients with tuberculosis * Patients documented with active COVID

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia (AML)

Contacts and locations

Locations

  • CHU of Nantes

    Nantes, 44093, France

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