Study With Tocilizumab in Combination With Venetoclax and Azacitidine Chemotherapy in Patients With Acute Myeloid Leukemia

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

First-line AML regardless of karyotype and molecular profile

ECOG <= 3

Patient eligible for chemotherapy combining azacitidine and venetoclax

Informed consent

Disqualifiers

LAM3

Patients eligible for intensive "3+7" treatment

Uncontrolled infection

Active and/or treated infection with Hep B, C, or HIV

Trial design

Design model

Single group

Treatments tested in this trial

  • increase dose of tocilizumab

    Drug

    Combining tocilizumab with the standard treatment of azacitidine and venetoclax

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: TocilizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

DLT

number of DLT

Time frame
42 days

Secondary outcomes

1

response to treatment

number of response

Time frame
28 months
2

response to treatment

number of response without detectable residual disease

Time frame
28 months
3

Death

number of days between Day 1 and Death

Time frame
48 months
4

follow - up

number of days between Day 1 and follow - up date

Time frame
48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: