Clinical Trials

Multiple clinical trials evaluate amsacrine hydrochloride primarily for hematologic malignancies—including acute myeloid leukemia, acute nonlymphocytic leukemia, myelodysplastic syndromes, and chronic myelomonocytic leukemia—as well as out-of-hospital cardiac arrest. Spanning Phase 1 through Phase 4 alongside unassigned protocols, these studies are sponsored by academic institutions and cooperative research groups such as the European Organisation for Research and Treatment of Cancer. Across completed, recruiting, terminated, and unknown recruitment statuses, trials assess amsacrine within sequential conditioning regimens for secondary leukemia, intensive leukemia therapy, and cardiac arrest interventions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05807932 RECRUITING
Myelodysplastic Syndromes; Secondary Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia
Heinrich-Heine University, Duesseldorf
 2023-06-26 PHASE1; PHASE2
NCT03765541 TERMINATED
Relapsed or Refractory Acute Myeloid Leukemia
University Hospital, Toulouse
 2020-01-13 PHASE3
NCT01228331 COMPLETED
Leukemia
Universitätsklinikum Hamburg-Eppendorf
 2010-10 PHASE2; PHASE3
NCT04997980 Completed
Out-Of-Hospital Cardiac Arrest
IRCCS Policlinico S. Matteo|University of the Basque Country (UPV/EHU)|Oslo University Hospital|The Hospital of Vestfold
 2015-01-01 --
NCT00840684 COMPLETED
Leukemia
Institut Paoli-Calmettes
 2009-01 PHASE1; PHASE2
NCT00180102 COMPLETED
Leukemia, Nonlymphocytic, Acute
Technische Universität Dresden
 2003-12 PHASE4
NCT00002719 COMPLETED
Leukemia; Neutropenia
European Organisation for Research and Treatment of Cancer - EORTC
 1995-12 PHASE3
NCT01324063 COMPLETED
Leukemia
European Organisation for Research and Treatment of Cancer - EORTC
 1986-11 PHASE3
NCT00003436 COMPLETED
Leukemia; Myelodysplastic Syndromes
Medical Research Council
 1998-07 PHASE3
NCT00002658 UNKNOWN
Leukemia; Neutropenia
Medical Research Council
 1994-01 PHASE3

(data from https://clinicaltrials.gov, updated on 2024-05-01)

Check the Amsacrine hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amsacrine hydrochloride intercalates into genomic DNA and stabilizes the topoisomerase II-DNA cleavable complex, preventing DNA religation and generating lethal double-strand breaks. This accumulation of DNA damage disrupts nucleic acid synthesis and triggers apoptotic death in proliferating neoplastic cells, underlying its therapeutic utility in treating acute myeloid leukemia and related myelodysplastic disorders.

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>).

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Note: Technical data last updated: Sep 1, 2026.