124 completed, 25 recruiting, 20 terminated, 18 unknown. 106 Phase 2, 47 Phase 3, 44 Phase 1, 15 Not applicable, 9 Phase 4.
Follow Hydroxyurea: new trials by email Literature Review of Hydroxyurea trials Research Report on Hydroxyurea
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard Therapy Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy - Acute Myeloid Leukemia | Phase 2 | Recruiting | Uma Borate | 70 | 2027-01-15 | 2026-11-09 |
| A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients OTS-412, Hydroxyurea (HU), Atezolizumab - Treatment-Refractory Solid Tumors | Phase 1 | Not yet recruiting | Bionoxx Inc. | 24 | 2027-01-01 | 2026-08-26 |
| Addition of Hydroxyurea to Fludarabine, Cytarabine, Idarubicin and Venetoclax Salvage Therapy for Adults With Relapsed or Refractory Acute Myeloid Leukemia Hydroxycarbamid - R/R AML | Phase 1 / Phase 2 | Not yet recruiting | Christer C Nilsson | 26 | 2026-10-01 | 2026-08-17 |
| Clinical Utility of Urinary N-Acetyl-β-D-Glucosaminidase (NAG), Kidney Injury Molecule-1 (KIM-1), and Diffusion-Weighted Renal MRI for the Early Detection of Sickle Cell Nephropathy in Children Hydroxy Urea - Sickle Cell Nephropathy | Not yet recruiting | Assiut University | 90 | 2026-10-01 | 2026-08-25 | |
| Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell Disease Cyclophosphamide 50mg, Abatacept, Alemtuzumab - Sickle Cell Disease | Phase 2 | Recruiting | St. Jude Children's Research Hospital | 45 | 2026-09-10 | 2026-11-12 |
| Safety and Efficacy of Hemoglobin F Inducers in Patients With Beta Thalassemia Thalidomide, Hydroxy Urea - Thalassemia | Not applicable | Recruiting | Riphah International University | 240 | 2026-06-20 | 2026-08-06 |
| Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET, Ivosidenib Oral Tablet, Hydroxyurea - Acute Myeloid Leukemia With Gene Mutations | Phase 2 | Recruiting | PETHEMA Foundation | 50 | 2026-06-12 | 2026-09-22 |
| Optimizing Hydroxyurea Therapy in Children With Sickle Cell Anemia In Malaria Endemic Areas: The NOHARM Maximum Tolerated Dose (MTD) Study hydroxycarbamide - Sickle Cell Disease, Sickle Cell Anemia in Children | Phase 1 / Phase 2 | Recruiting | Children's Hospital Medical Center, Cincinnati | 250 | 2026-05-13 | 2026-07-16 |
| Hydroxyurea Optimisation in Sickle Cell Disease Hydroxyurea (HU) - Sickle Cell Disease | Recruiting | Ochuko Orherhe | 100 | 2026-05-08 | 2026-10-27 | |
| A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients (South Korea) OTS-412, Hydroxyurea (HU), Atezolizumab - Treatment-Refractory Solid Tumors | Phase 1 | Recruiting | Bionoxx Inc. | 21 | 2026-03-09 | 2026-11-04 |
| Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Autologous Anti-CD83 CAR T-cells, Biospecimen Collection, Chest Radiography - Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia | Phase 1 | Recruiting | Roswell Park Cancer Institute | 26 | 2026-02-02 | 2026-10-27 |
| Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia Pacritinib, Hydroxyurea - Leukemia, Myelomonocytic, Chronic | Phase 2 | Recruiting | Theradex | 66 | 2026-01-01 | 2026-08-18 |
| PASS of Xromi Comparing Safety and Effectiveness in Children Under 2 Years With Sickle Cell Disease [PRECISE PASS] Xromi - Sickle Cell Disease | Recruiting | Nova Laboratories Limited | 180 | 2025-06-09 | 2026-03-05 | |
| 177Lu-DOTATATE for Recurrent Meningioma Local standard of Care, 177Lu-DOTATATE - Recurrent Meningioma | Phase 2 | Recruiting | European Organisation for Research and Treatment of Cancer - EORTC | 136 | 2025-03-10 | 2026-06-15 |
| Pharmacokinetics, Efficacy and Safety of Twice Daily Dosing Regimen of Hydroxycarbamide Dispersible Tablets in Children With Sickle Cell Disease Hydroxycarbamid - Sickle Cell Disease | Phase 2 | Recruiting | Theravia | 50 | 2025-01-21 | 2026-10-01 |
| Stroke Prevention in Nigeria 2 Trial Hydroxyurea - Sickle Cell Disease, Stroke | Phase 4 | Recruiting | Vanderbilt University Medical Center | 220 | 2024-08-05 | 2026-03-05 |
| Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007) Bomedemstat, Hydroxyurea, Bomedemstat placebo - Essential Thrombocythemia | Phase 3 | Active not recruiting | Merck Sharp & Dohme LLC | 300 | 2024-07-16 | 2026-08-27 |
| A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML/HR-MDS Patients Hydroxyurea, Hydroxycarbamide, Valproic acid, 6-Mercaptopurine (6-MP) - Acute Myeloid Leukemia, Adult, Myelodysplastic Syndromes, Adult | Phase 1 / Phase 2 | Recruiting | Haukeland University Hospital | 48 | 2024-05-23 | 2025-06-29 |
| Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera Givinostat, Hydroxyurea - Polycythemia Vera | Phase 3 | Recruiting | Italfarmaco | 220 | 2024-03-26 | 2026-03-25 |
| Combination of Thalidomide and Hydroxyuria in Transfusion Dependent Thalasemmia ADDITION OF THALIDOMIDE AND HYDROXYUREA - Transfusion Dependent Beta Thalassemia | Phase 2 | Completed | Pakistan Blood and Marrow Transplant (PBMT) Group | 100 | 2024-01-01 | 2026-05-05 |
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Anemia, Sickle Cell (74) · HIV Infections (16) · beta-Thalassemia (12) · Polycythemia Vera (11) · Brain Neoplasms (10) · Stroke (10) · Glioblastoma (9) · Leukemia (9) · Leukemia, Myelogenous, Chronic, BCR-ABL Positive (9) · Leukemia, Myeloid, Chronic-Phase (9) · Squamous Cell Carcinoma of Head and Neck (9) · Hematologic Diseases (8) · Leukemia, Myeloid, Acute (8) · Head and Neck Neoplasms (7) · Hemoglobinopathies (7)
National Heart, Lung, and Blood Institute (NHLBI) (11) · Children's Hospital Medical Center, Cincinnati (10) · University of Chicago (10) · St. Jude Children's Research Hospital (8) · Duke University (7) · Vanderbilt University Medical Center (7) · National Cancer Institute (NCI) (6) · National Institute of Allergy and Infectious Diseases (NIAID) (6) · Theravia (6) · Bristol-Myers Squibb (4) · Baylor College of Medicine (3) · Novartis Pharmaceuticals (3) · Paul Szabolcs (3) · AOP Orphan Pharmaceuticals AG (2) · Annick Desjardins (2)
United States (109) · France (26) · Italy (17) · United Kingdom (17) · Germany (16) · Nigeria (12) · Spain (11) · Hungary (8) · Pakistan (8) · Poland (8) · Canada (7) · China (7) · Uganda (7) · Netherlands (6) · Austria (5)
Russell Ware, MD, PhD (5) · Everett Vokes, MD (4) · Russell E. Ware, MD, PhD (4) · John F Tisdale, M.D. (3) · Michael R. DeBaun, MD, MPH (3) · Ruediger Hehlmann, MD (3) · Ahmed F Mahmoud Hussein, MS.c (2) · Annick Desjardins, MD, FRCPC (2) · Ari Rosenberg, MD (2) · David A. Reardon, MD (2) · Dr Ching H. Wang (2) · Everett E. Vokes, MD (2) · James F. Casella, MD (2) · Jeremie Estepp, MD (2)
PMID 41026975, PMID 30952488, PMID 35477175, PMID 36240296, PMID 41954645, PMID 12074329, PMID 14668455, PMID 14668456, PMID 15010373, PMID 15187476, PMID 15597521, PMID 16048984, PMID 16103764, PMID 16267764, PMID 16810109, PMID 16849759, PMID 17146105, PMID 17315155, PMID 17662759, PMID 18478575, PMID 19248046, PMID 19291085, PMID 19621454, PMID 19813252, PMID 19856395, PMID 19880138, PMID 19965667, PMID 20142590, PMID 20467286, PMID 20797449, PMID 20830768, PMID 21217080, PMID 21275961, PMID 21422420, PMID 21571150, PMID 21586746, PMID 21606305, PMID 21744485, PMID 21826782, PMID 21938530, PMID 22190441, PMID 22294512, PMID 22318199, PMID 22915643, PMID 23216616, PMID 23315161, PMID 23841729, PMID 23861242, PMID 23927461, PMID 23999955
2008 (2), N01HB07160 (2), R01NS094041 (2), U10CA031946 (2), 2004 (1), 2009 (1), 2017 (1), 2018 (1), 2023 (1), 3UL1RR025005 (1), N01CM62201 (1), N01HB07150 (1), N01HB07151 (1), N01HB07152 (1), N01HB07153 (1)