Pixantrone Maleate Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Multiple clinical trials evaluate the therapeutic profile of pixantrone maleate across Phase 1, Phase 2, and Phase 3 studies for hematologic malignancies and solid tumors, such as non-Hodgkin lymphoma, diffuse large B-cell lymphoma, acute myelogenous leukemia, and metastatic breast cancer. Sponsored by both commercial entities and academic research organizations, these protocols report varied recruitment statuses, including completed, active non-recruiting, terminated, and withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03458260	COMPLETED	Aggressive Non-Hodgkin Lymphoma	The Lymphoma Academic Research Organisation	2018-12-26	PHASE2
NCT02678299	UNKNOWN	Malignant Lymphoma	University of Aarhus	2016-02	PHASE1; PHASE2
NCT02499003	COMPLETED	Lymphoma, Non-Hodgkin	Johannes Gutenberg University Mainz	2015-08-14	PHASE2
NCT02800889	WITHDRAWN	Lymphoma; Solid Tumor (Excluding CNS)	CTI BioPharma	2016-10-24	PHASE1
NCT01321541	COMPLETED	Diffuse Large B-cell Lymphoma; de Novo DLBCL; DLBCL Transformed From Indolent Lymphoma; Follicular Grade 3 Lymphoma	CTI BioPharma	2011-04-20	PHASE3
NCT01632436	WITHDRAWN	Metastatic Cancer	CTI BioPharma	2012-05	PHASE1
NCT01491841	COMPLETED	Non-Hodgkin's Lymphoma	Anne Beaven, MD	2011-11-01	PHASE1
NCT00577161	WITHDRAWN	Non-Hodgkin's Lymphoma	CTI BioPharma	2007-09	PHASE3
NCT00268853	COMPLETED	Diffuse Large-Cell Lymphoma	CTI BioPharma	2005-11	PHASE2
NCT01086605	COMPLETED	Breast Cancer	Alliance for Clinical Trials in Oncology	2010-05	PHASE2
NCT00088530	COMPLETED	Lymphoma, Non-Hodgkin	CTI BioPharma	2004-07	PHASE3
NCT00060671	TERMINATED	Lymphoma, Follicular; Lymphoma, Mixed-Cell, Follicular; Lymphoma, Small Cleaved-Cell, Follicular; Lymphoma, Low-Grade	CTI BioPharma	2005-01	PHASE3
NCT00106600	Completed	Acute Myelogenous Leukemia	CTI BioPharma	2005-03	Phase 1\|Phase 2
NCT00060684	COMPLETED	Lymphoma, Low-Grade; Lymphoma, Small Lymphocytic; Lymphoma, Mixed-Cell, Follicular; Lymphoma, Small Cleaved-Cell, Follicular	CTI BioPharma	2001-12	PHASE1
NCT00060671	Terminated	Lymphoma Follicular\|Lymphoma Mixed-Cell Follicular\|Lymphoma Small Cleaved-Cell Follicular\|Lymphoma Low-Grade	CTI BioPharma	2005-01	Phase 3
NCT00551239	WITHDRAWN	Leukemia; Lymphoma	CTI BioPharma	2007-08	PHASE3
NCT00069966	UNKNOWN	Lymphoma	Theradex	2003-04	PHASE2
NCT00053105	UNKNOWN	Lymphoma	Theradex	2002-02	PHASE1
NCT00106600	COMPLETED	Acute Myelogenous Leukemia	CTI BioPharma	2005-03	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-03-10)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pixantrone maleate acts as a weak topoisomerase II inhibitor and alkylating agent that targets DNA hypermethylated sites, forming stable DNA adducts that disrupt replication machinery to induce cellular apoptosis. This targeted DNA disruption suppresses rapidly proliferating neoplastic cells, underpinning its therapeutic relevance in treating hematologic malignancies such as non-Hodgkin lymphoma and acute myelogenous leukemia.

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>).