25 completed, 8 recruiting, 3 active not recruiting, 3 unknown. 44 Phase 1, 19 Phase 2.
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer Paclitaxel, Carboplatin, Cetuximab - HPV-Negative Squamous Cell Carcinoma | Phase 1 | Recruiting | University of Chicago | 36 | 2023-12-18 | 2025-06-08 |
| A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS) CF33-CD19 IT Monotherapy, CF33-CD19 IV Monotherapy, CF33-CD19 IT Combination - Solid Tumor, Adult | Phase 1 | Terminated | Imugene Limited | 25 | 2023-10-02 | 2026-03-06 |
| Hydroxyurea and EPO in Sickle Cell Disease Hydroxyurea, Epoetin Alfa-BioSimilar - Anemia, Sickle Cell, Sickle Cell Disease | Phase 1 / Phase 2 | Completed | Julia Xu | 17 | 2023-05-25 | 2026-01-07 |
| Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer Chemoradiation, Pamiparib, Hydroxyurea - Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma | Phase 1 | Recruiting | University of Chicago | 30 | 2023-03-07 | 2026-03-04 |
| Addition of JSP191 (C-kit Antibody) to Nonmyeloablative Hematopoietic Cell Transplantation for Sickle Cell Disease and Beta-Thalassemia TBI, Hydroxyurea, briquilimab - Sickle Cell Anemia, Beta Thalassemia | Phase 1 / Phase 2 | Active not recruiting | National Heart, Lung, and Blood Institute (NHLBI) | 40 | 2022-05-12 | 2026-03-12 |
| A Bioequivalence Study to Compare the Pharmacokinetics of Two Formulations of Hydroxycarbamide in Healthy Volunteers Hydroxycarbamide dispersible tablets, Hydroxycarbamide film-coated tablet - Healthy Volunteers | Phase 1 | Completed | Theravia | 28 | 2021-07-30 | 2026-09-29 |
| Pharmacokinetics of Oral Hydroxyurea Solution Oral Hydroxyurea (100 mg/mL) Solution - Sickle Cell Disease, Sickle-Cell; Hemoglobin Disease, Thalassemia | Phase 1 / Phase 2 | Completed | Nova Laboratories Limited | 33 | 2019-01-03 | 2024-10-28 |
| T-Cell Depleted Alternative Donor Bone Marrow Transplant for Sickle Cell Disease (SCD) and Other Anemias CD3/CD19 depleted leukocytes, CD45RA depleted leukocytes, Hydroxyurea - Sickle Cell Anemia, Beta-thalassemia Major | Phase 1 / Phase 2 | Recruiting | Paul Szabolcs | 5 | 2018-08-02 | 2026-08-13 |
| Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure CD3/CD19 negative hematopoietic stem cells, Rituximab, Alemtuzumab - Idiopathic Pulmonary Fibrosis, Emphysema or COPD | Phase 1 / Phase 2 | Recruiting | Paul Szabolcs | 8 | 2018-04-19 | 2026-01-13 |
| Hydroxy-urea and Temozolomide in Patients With a Recurrent Malignant Brain Tumor (Glioblastoma) Hydroxyurea, Temozolomide - Glioma, Glioblastoma | Phase 1 | Unknown | M.E. van Linde | 54 | 2018-03-02 | 2020-10-08 |
| Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease haploidentical stem cell transplant, Sirolimus, Alemtuzumab - Sickle Cell Disease | Phase 1 / Phase 2 | Active not recruiting | National Heart, Lung, and Blood Institute (NHLBI) | 57 | 2017-04-06 | 2026-04-23 |
| Assessment of Algorithm-Based Hydroxyurea Dosing on Fetal Hemoglobin Response, Acute Complications, and Organ Function in People With Sickle Cell Disease Hydroxyurea - Sickle Cell Disease | Phase 1 / Phase 2 | Completed | National Heart, Lung, and Blood Institute (NHLBI) | 10 | 2014-08-23 | 2019-08-06 |
| Realizing Effectiveness Across Continents With Hydroxyurea (REACH) Hydroxyurea - Sickle Cell Disease | Phase 1 / Phase 2 | Active not recruiting | Children's Hospital Medical Center, Cincinnati | 635 | 2014-06-01 | 2026-06-30 |
| Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients SANGUINATE™, Hydroxyurea - Sickle Cell Disease | Phase 1 | Completed | Prolong Pharmaceuticals | 24 | 2013-05-01 | 2014-12-03 |
Showing 20 of 44. Sign in to see all of them.
Anemia, Sickle Cell (15) · Glioblastoma (5) · Squamous Cell Carcinoma of Head and Neck (5) · Gliosarcoma (4) · Brain Neoplasms (3) · Glioma (3) · HIV Infections (3) · Anemia (2) · Anemia, Diamond-Blackfan (2) · Central Nervous System Neoplasms (2) · Head and Neck Neoplasms (2) · Hematologic Diseases (2) · Hemoglobinopathies (2) · Hypertension, Pulmonary (2) · Leukemia, Myeloid, Acute (2)
National Cancer Institute (NCI) (4) · National Heart, Lung, and Blood Institute (NHLBI) (4) · University of Chicago (3) · Annick Desjardins (2) · Bionoxx Inc. (2) · Children's Hospital Medical Center, Cincinnati (2) · Duke University (2) · Paul Szabolcs (2) · Stanford University (2) · Ann & Robert H Lurie Children's Hospital of Chicago (1) · Children's Mercy Hospital Kansas City (1) · Christer C Nilsson (1) · Dartmouth-Hitchcock Medical Center (1) · GERCOR - Multidisciplinary Oncology Cooperative Group (1) · Haukeland University Hospital (1)
United States (30) · Uganda (2) · United Kingdom (2) · Angola (1) · Canada (1) · Colombia (1) · Democratic Republic of the Congo (1) · France (1) · Jamaica (1) · Kenya (1) · Netherlands (1) · Nigeria (1) · Norway (1) · Panama (1) · South Korea (1)
John F Tisdale, M.D. (3) · Ari Rosenberg, MD (2) · Dr Ching H. Wang (2) · Angel Hernandez, MD (1) · Angela E Rankine- Mullings, MD (1) · Annelize Koch, MD (1) · Annick Desjardins, MD (1) · Annick Desjardins, MD, FRCPC (1) · Brian G. Fuller, MD (1) · Chelsea Peterson, DO (1) · Christer C Nilsson, MD PhD (1) · Courtney D Fitzhugh, M.D. (1) · Courtney F Joseph, M.D. (1) · David A. Reardon, MD (1)
PMID 15597521, PMID 19248046, PMID 24296492, PMID 26275071, PMID 28884840, PMID 29318647, PMID 30501550, PMID 32672489, PMID 35945244, PMID 36240296, PMID 38701812, PMID 41026975, PMID 41871072, PMID 41954645, PMID 42133908
2017 (1), N01CM62201 (1), U10CA031946 (1), U10CA180821 (1)