Single-centre Phase I/II study with dose escalation of tocilizumab in combination with venetoclax and azacitidine chemotherapy in patients with Acute Myeloid Leukaemia (AML): TOCIVENA

2025-524725-41-00 Protocol RC25_0533 Human pharmacology (Phase I) - Other Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol RC25_0533

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Authorised, recruitment pending
Participants planned 12
Countries 1
Sites 1

Acute Myeloblastic Leukemia

Key facts

Sponsor
Centre Hospitalier Universitaire De Nantes
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Not possible to specify
Decision date (initial)
2026-04-10
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Acute Myeloblastic Leukemia

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nantes

Sponsor organisation
Centre Hospitalier Universitaire De Nantes
Address
5 Allee De L Ile Gloriette, Cs 69301 Cs 69301
City
Nantes Cedex 1
Postcode
44093
Country
France

Scientific contact point

Organisation
Centre Hospitalier Universitaire De Nantes
Contact name
Study Coordinator

Public contact point

Organisation
Centre Hospitalier Universitaire De Nantes
Contact name
Study Coordinator

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Authorised, recruitment pending 12 1
Rest of world 0

Investigational sites

France

1 site · Authorised, recruitment pending
Centre Hospitalier Universitaire De Nantes
Hematological, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-01-19 France Acceptable
2026-04-10
2026-04-10