Alaunos Therapeutics trial of darinaparsin in blood cancers ended early, record updated

A phase 2 clinical trial testing darinaparsin, also known as ZIO-101, in patients with advanced blood and bone marrow cancers was terminated before reaching full enrollment, according to a ClinicalTrials.gov record (NCT00421213) updated September 30, 2026. The study's lead sponsor is listed as Alaunos Therapeutics.¹

The registry record states that the sponsor halted enrollment at 50 of the 70 patients originally planned because it had observed a signal of activity in lymphoma patients, and concluded that enrolling more patients would not meaningfully change the interpretation of the drug's efficacy or safety.¹

The trial began on December 29, 2006, with both primary completion and study completion listed as June 30, 2009.¹ It was first posted to the registry on January 11, 2007.

The study tested darinaparsin, dosed at 300mg per square meter and administered daily for five consecutive days, with the cycle repeated every 28 days for up to six months.¹ Patients enrolled had hematologic neoplasms, bone marrow neoplasms, or non-Hodgkin's lymphoma,¹ and the trial used a single-arm, non-randomized design with no masking.¹

The primary outcome measure was response rate assessed over a six-month time frame,¹ with toxicities tracked as a secondary outcome over the same period.

The study enrolled patients at six sites across the United States, located in Miami, Florida; Chicago, Illinois; Bethesda, Maryland; Fargo, North Dakota; Sioux Falls, South Dakota; and Morgantown, West Virginia.¹