Azacitidine — Drug Intelligence | 66 EU Trials

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66 Registered trials

23 Recruiting

38 Completed trials

41 Sponsors

21 Countries

Phase III

Phase II

Phase I/II

Phase III: 21 Phase II/III: 3 Phase II: 27 Phase I/II: 10 Phase I (Other): 1 Phase I (FiH): 4

Oversight events:

5 serious breaches 5 temporary halts 3 corrective measures across 5 trials

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Indications tested

Acute myeloid leukaemia 10 Myelodysplastic syndrome 10 Chronic myelomonocytic leukaemia 2 Non-small cell lung cancer recurrent 1 Non-small cell lung cancer metastatic 1 Systemic mastocytosis 1 Non-small cell lung cancer stage IV 1 Bone marrow failure 1 Non-small cell lung cancer 1 Non-small cell lung cancer stage IIIB 1 Acute myeloid leukaemia (in remission) 1 Myelofibrosis 1

Sponsors using this IMP

AbbVie Deutschland GmbH & Co. KG 5 Celgene Corp. 4 Groupe Francophone Des Myelodysplasies 4 Institut De Recherches Internationales Servier IRIS 3 Syros Pharmaceuticals Inc. 3 Technische Universitat Dresden 3 Ascentage Pharma Group Inc. 2 Centre Hospitalier Regional De Marseille 2 Fondazione Gimema Franco Mandelli Onlus 2 French Innovative Leukemia Organization 2 Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting 2 Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. 2

All trials

66 total

A PRECISION MEDICINE RANDOMIZED TRIAL FOR PATIENTS WITH RELAPSED OR REFRACTORY T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA BASED ON A FUNCTIONAL APP… Pending

2024-516570-30-00 Phase II 5 countries Centre Hospitalier De Versailles
FILO-AML-01-MIVONU A single arm phase II study investigating the efficacy and safety of the addition of ivosidenib to oral azacitidine (Onur… Pending

2025-521322-14-00 Phase II 1 country French Innovative Leukemia Organization
A Phase II, Open-Label Randomized Study of Intravenous Tambiciclib in Combination with the Standard of care Venetoclax and Azacitidine in Pa… Pending

2025-524308-31-00 Phase II 2 countries IIS La Fe; Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
A study testing the new drug Lisaftoclax for newly diagnosed acute myeloid leukemia(GLORA-3) Recruiting

2024-516436-10-00 Phase III 3 countries Ascentage Pharma Group Inc.
Studies testing Ziftomenib together with standard treatments in adults with newly diagnosed acute myeloid leukemia (AML) that has specific g… Recruiting

2025-521314-25-00 Phase III 10 countries Kura Oncology Inc.
A study to investigate the effect of adding venetoclax to treatment with ivosidenib and azacitidine in patients with acute myeloid leukemia … Recruiting

2024-512753-24-00 Phase III 14 countries Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
A study investigating the effect of adding revumenib to treatment with venetoclax + azacitidine in patients with acute myeloid leukemia (AML… Recruiting

2024-512733-32-00 Phase III 14 countries Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
IMPACT-AML: A RANDOMIZED PRAGMATIC CLINICAL TRIAL FOR RELAPSE OR REFRACTORY ACUTE MYELOID LEUKEMIA Recruiting

2024-514517-35-00 Phase III 7 countries Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
A Phase 3b study to learn more about the safety and tolerability of ivosidenib in combination with azacitidine in adult patients newly diagn… Recruiting

2022-501709-11-00 Phase III 11 countries Servier Affaires Medicales
A Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) plus BSC versus Placebo plus BSC in Participants with IPS… Recruiting

2022-500479-29-00 Phase II/III 10 countries Celgene Corp.
A Randomized, Open-labelled, Multicenter Trial Evaluating Efficacy and Safety of A Reduced Venetoclax Exposure To Seven Days Versus Standard… Recruiting

2025-521634-29-00 Phase III 2 countries Institut Gustave Roussy
STOP VEN-IPC 2024-001 DE-ESCALATION STUDY EVALUATING VENETOCLAX AND AZACITIDINE DISCONTINUATION IN AML RESPONDING PATIENTS Recruiting

2024-514112-28-00 Phase II 1 country Institut Paoli Calmettes
PLATFORM - A PLATFORM TRIAL, EVALUATING NEW DRUGS OR COMBINATION IN RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMAS Recruiting

2024-514954-63-00 Phase I/II 1 country LYSARC
A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Recruiting

2024-520154-38-00 Phase III 12 countries Janssen Cilag International
A Study of ASTX030 (Cedazuridine in Combination with Azacitidine) in MDS, CMML, or AML Recruiting

2024-515098-93-00 Phase III 7 countries Taiho Oncology Inc.
A study to evaluate the efficacy of APG-2575 (Lisaftoclax) plus azacitidine (AZA) vs. placebo plus AZA in newly diagnosed adult subjects wit… Recruiting

2024-517247-31-00 Phase III 13 countries Ascentage Pharma Group Inc.
A Phase 3, multicenter, open label, randomized, non-comparative two-arm study of ivosidenib monotherapy (IVO) and azacitidine monotherapy (A… Recruiting

2023-510155-37-00 Phase III 5 countries Institut De Recherches Internationales Servier IRIS
Sequential Gilteritinib in Combination with Venetoclax and Azacitidine for Patients with Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mut… Recruiting

2023-507878-41-00 Phase II 1 country Technische Universitat Dresden
VEX-AZA: Treating VEXAS Syndrome with Azacitidine. A Single-Arm, Multicenter Phase II Study on the Efficacy and Safety of Azacitidine in Pat… Recruiting

2024-510715-30-00 Phase II 4 countries Rigshospitalet
PHASE II STUDY OF AZACITIDINE IN COMBINATION WITH LOW DOSE INTENSITY VENETOCLAX IN PATIENTS WITH ACUTE MYELOID LEUKEMIA WITH INTEGRATION OF … Recruiting

2023-510415-19-00 Phase II 4 countries Rigshospitalet
Venetoclax plus azacitidine versus standard intensive chemotherapy for patients with newly diagnosed acute myeloid leukemia (AML) and NPM1 m… Recruiting

2024-515267-59-00 Phase II 1 country Technische Universitaet Dresden
A study to investigate the effect of adding cobicistat to venetoclax and azacitidine in patients with acute myeloid leukemia (AML) who are i… Recruiting

2023-505379-61-00 Phase II 1 country Haemato Oncology Foundation For Adults Netherlands
Venetoclax in children with relapsed AML Recruiting

2023-510160-12-00 Phase III 14 countries Prinses Maxima Centrum voor Kinderoncologie B.V.
Study of BGB-11417 in Patients with Myeloid Malignancies Recruiting

2023-508881-14-00 Phase I/II 4 countries BeOne Medicines AG

Showing 1–24 of 66 trials

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