Numerous clinical trials spanning early to late phases evaluate dexrazoxane primarily for anthracycline-induced cardiac toxicity, chemotherapy extravasation, pediatric solid tumors, acute myeloid leukemia, and sarcomas. Supported by academic institutions, industrial entities, and research consortia such as the National Cancer Institute and Children's Oncology Group, these studies encompass various recruitment statuses ranging from actively recruiting and completed to terminated and withdrawn protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07654426 | RECRUITING | Diffuse Large B-cell Lymphoma (DLBCL); Cardiotoxicity; Lymphoma |
Beth Israel Deaconess Medical Center |
2026-08-31 | PHASE2 |
| NCT03126916 | RECRUITING | Ganglioneuroblastoma; Ganglioneuroblastoma, Nodular; Neuroblastoma |
Children's Oncology Group |
2018-05-14 | PHASE3 |
| NCT04293562 | RECRUITING | Acute Myeloid Leukemia |
Children's Oncology Group |
2020-07-21 | PHASE3 |
| NCT06647953 | RECRUITING | Pleuropulmonary Blastoma |
Children's Oncology Group |
2025-03-21 | PHASE3 |
| NCT06220032 | RECRUITING | DLBCL - Diffuse Large B Cell Lymphoma |
Stichting Hemato-Oncologie voor Volwassenen Nederland |
2024-08-15 | PHASE3 |
| NCT05292664 | RECRUITING | Myelodysplastic Syndromes, de Novo; Myelodysplastic Syndromes, Secondary; Myelodysplastic Syndromes, Previously Treated; Treatment-Related Acute Myeloid Leukemia; Therapy-Related Myelodysplastic Syndrome; Acute Lymphoblastic Leukemia, in Relapse; Acute Lymphoblastic Leukemia With Failed Remission; Lymphoblastic Lymphoma, in Relapse; Lymphoblastic Lymphoma, Refractory; Acute Leukemia of Ambiguous Lineage in Relapse; Acute Leukemia of Ambiguous Lineage |
Andrew E. Place, MD |
2023-03-29 | PHASE1 |
| NCT06262438 | RECRUITING | Acute Myeloid Leukemia in Children |
Princess Maxima Center for Pediatric Oncology |
2024-02-06 | PHASE2 |
| NCT03589729 | RECRUITING | Acute Myeloid Leukemia; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Blasts 10 Percent or More of Bone Marrow Nucleated Cells; High Risk Myelodysplastic Syndrome; Myeloid Sarcoma; Myeloproliferative Neoplasm; Philadelphia Chromosome Positive |
M.D. Anderson Cancer Center |
2018-09-19 | PHASE2 |
| NCT00077285 | ACTIVE_NOT_RECRUITING | Sarcoma |
Memorial Sloan Kettering Cancer Center |
2003-10 | PHASE2 |
| NCT01864109 | ACTIVE_NOT_RECRUITING | Newly Diagnosed Ewing Sarcoma |
Memorial Sloan Kettering Cancer Center |
2013-05 | PHASE2 |
| NCT01871766 | ACTIVE_NOT_RECRUITING | Rhabdomyosarcoma |
St. Jude Children's Research Hospital |
2013-12-04 | PHASE2 |
| NCT03020030 | ACTIVE_NOT_RECRUITING | Acute Lymphoblastic Leukemia, Pediatric |
Dana-Farber Cancer Institute |
2017-03-03 | PHASE3 |
| NCT03007147 | ACTIVE_NOT_RECRUITING | Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia; Mixed Phenotype Acute Leukemia; T Acute Lymphoblastic Leukemia |
Children's Oncology Group |
2017-08-08 | PHASE3 |
| NCT07502521 | COMPLETED | Acute Myocardial Infarction (AMI) |
Rohan Dharmakumar |
2025-08-30 | PHASE2 |
| NCT03164057 | ACTIVE_NOT_RECRUITING | Acute Myeloid Leukemia; Myelodysplastic Syndromes |
St. Jude Children's Research Hospital |
2017-06-15 | PHASE2 |
| NCT05858710 | COMPLETED | Sarcoma, Soft Tissue |
Thermosome GmbH |
2023-04-19 | PHASE1 |
| NCT03930680 | COMPLETED | Degradation of Top2b and Top2a in Human by Dexrazoxane; Time Course and Degradation of Top2b in Human by Dexrazoxane; Effects of Dexrazoxane on Healthy Human |
University of Arkansas |
2021-09-14 | PHASE1 |
| NCT02584309 | COMPLETED | Sarcoma, Soft Tissue; Soft Tissue Sarcoma; Undifferentiated Pleomorphic Sarcoma; Leiomyosarcoma; Liposarcoma; Synovial Sarcoma; Myxofibrosarcoma; Angiosarcoma; Fibrosarcoma; Malignant Peripheral Nerve Sheath Tumor; Epithelioid Sarcoma |
Washington University School of Medicine |
2016-02-22 | PHASE2 |
| NCT03786783 | COMPLETED | Ganglioneuroblastoma; High Risk Neuroblastoma |
National Cancer Institute (NCI) |
2019-03-04 | PHASE2 |
| NCT04997291 | UNKNOWN | Heart Defects, Congenital |
University of Texas at Austin |
2021-04-09 | PHASE1 |
| NCT00980460 | COMPLETED | PRETEXT I Hepatoblastoma; PRETEXT II Hepatoblastoma; PRETEXT III Hepatoblastoma; PRETEXT IV Hepatoblastoma |
National Cancer Institute (NCI) |
2009-09-15 | PHASE3 |
| NCT03698227 | TERMINATED | Advanced Soft Tissue Sarcoma |
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
2018-11-12 | PHASE2 |
| NCT01231906 | COMPLETED | Localized Extraskeletal Ewing Sarcoma; Peripheral Primitive Neuroectodermal Tumor of Bone; Peripheral Primitive Neuroectodermal Tumor of Soft Tissues |
Children's Oncology Group |
2010-11-24 | PHASE3 |
| NCT02953184 | UNKNOWN | Antineoplastic Combined Chemotherapy Protocols |
Jilin University |
2016-11 | PHASE2 |
| NCT01606878 | COMPLETED | Childhood Solid Neoplasm; Recurrent Childhood Anaplastic Large Cell Lymphoma; Recurrent Neuroblastoma |
Children's Oncology Group |
2013-04-29 | PHASE1 |
| NCT02519335 | TERMINATED | Heart Defects, Congenital |
Medical City Children's Hospital |
2014-09 | PHASE1 |
| NCT01523977 | COMPLETED | Acute Lymphoblastic Leukemia |
Dana-Farber Cancer Institute |
2011-11 | PHASE1 |
| NCT00038142 | TERMINATED | Ewing's Sarcoma |
M.D. Anderson Cancer Center |
1997-11 | PHASE2 |
| NCT01627938 | UNKNOWN | Multiple Sclerosis |
PD Dr. Andrew Chan |
2012-04 | PHASE2 |
| NCT00400946 | COMPLETED | Drug/Agent Toxicity by Tissue/Organ; Leukemia |
Dana-Farber Cancer Institute |
2005-04 | PHASE3 |
| NCT01596088 | COMPLETED | Extravasations of Anthracycline Anti-cancer Agents |
Kissei Pharmaceutical Co., Ltd. |
PHASE1; PHASE2 | |
| NCT00933985 | TERMINATED | Acute Leukemias of Ambiguous Lineage; Acute Undifferentiated Leukemia; Angioimmunoblastic T-cell Lymphoma; Blastic Phase Chronic Myelogenous Leukemia; Childhood Burkitt Lymphoma; Childhood Chronic Myelogenous Leukemia; Childhood Diffuse Large Cell Lymphoma; Childhood Immunoblastic Large Cell Lymphoma; Childhood Nasal Type Extranodal NK/T-cell Lymphoma; Cutaneous B-cell Non-Hodgkin Lymphoma; Hepatosplenic T-cell Lymphoma; Intraocular Lymphoma; Noncutaneous Extranodal Lymphoma; Peripheral T-cell Lymphoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Recurrent Childhood Anaplastic Large Cell Lymphoma; Recurrent Childhood Grade III Lymphomatoid Granulomatosis; Recurrent Childhood Large Cell Lymphoma; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Small Noncleaved Cell Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent/Refractory Childhood Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Hairy Cell Leukemia; Relapsing Chronic Myelogenous Leukemia; Small Intestine Lymphoma; Unspecified Childhood Solid Tumor, Protocol Specific |
National Cancer Institute (NCI) |
2009-06 | PHASE1 |
| NCT00742924 | COMPLETED | Sarcoma |
Children's Oncology Group |
2008-08 | PHASE1 |
| NCT00955890 | TERMINATED | Breast Cancer |
Fudan University |
2009-06 | PHASE2 |
| NCT00544778 | TERMINATED | Sarcoma |
City of Hope Medical Center |
2001-08 | PHASE2 |
| NCT01258634 | TERMINATED | Osteosarcoma; Lung Metastases |
University of Chicago |
2010-07 | PHASE1 |
| NCT00098839 | COMPLETED | Recurrent Childhood Acute Lymphoblastic Leukemia |
Children's Oncology Group |
2005-02 | PHASE1; PHASE2 |
| NCT00673179 | TERMINATED | Osteosarcoma |
M.D. Anderson Cancer Center |
2008-05 | |
| NCT00928200 | TERMINATED | Relapsed Acute Lymphoblastic Leukemia; Allergy to PEG e.Coli Asparaginase; Allergy to Native e.Coli Asparaginase |
Therapeutic Advances in Childhood Leukemia Consortium |
2009-04-13 | PHASE1 |
| NCT00084838 | COMPLETED | Central Nervous System Tumor, Pediatric |
Dana-Farber Cancer Institute |
2003-02 | PHASE2 |
| NCT00550901 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
City of Hope Medical Center |
2001-02 | PHASE1 |
| NCT00019864 | TERMINATED | Cardiac Toxicity; Sarcoma |
National Cancer Institute (NCI) |
2000-03 | PHASE2 |
| NCT00165087 | TERMINATED | Acute Lymphoblastic Leukemia |
Dana-Farber Cancer Institute |
1996-01 | PHASE3 |
| NCT00334867 | WITHDRAWN | Sarcoma |
Children's Oncology Group |
2005-12 | PHASE3 |
| NCT00039481 | COMPLETED | Cardiac Toxicity; Unspecified Childhood Solid Tumor, Protocol Specific |
National Cancer Institute (NCI) |
2002-11 | PHASE1 |
| NCT00548704 | COMPLETED | Extravasation |
Valerio Therapeutics |
2002-04 | PHASE2; PHASE3 |
| NCT00016276 | TERMINATED | Cardiac Toxicity; Inflammatory Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IV Breast Cancer |
National Cancer Institute (NCI) |
2001-05 | PHASE3 |
| NCT00002827 | COMPLETED | Cardiac Toxicity; Lymphoma |
Children's Oncology Group |
1996-10 | PHASE3 |
| NCT00005578 | COMPLETED | Cardiac Toxicity; Lymphoma |
Children's Oncology Group |
1997-03 | PHASE3 |
| NCT00003937 | COMPLETED | Cardiac Toxicity; Sarcoma |
Children's Oncology Group |
1999-09 | PHASE3 |
| NCT00548561 | COMPLETED | Anthracycline Extravasation |
Valerio Therapeutics |
2001-06 | PHASE2; PHASE3 |
| NCT01230983 | COMPLETED | Cardiac Toxicity; Leukemia; Lymphoma |
Children's Oncology Group |
1996-06 | PHASE3 |
| NCT00003667 | COMPLETED | Sarcoma |
Memorial Sloan Kettering Cancer Center |
1998-09 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-07-27)
Check the
Dexrazoxane
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.