Dose Ranging Trial for Pixantrone in the FND-R Variant Regimen in Indolent Non-Hodgkin's Lymphoma

Phase 1 Completed 30 enrolled CTI BioPharma

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The aim of this trial is to determine the appropriate dose of pixantrone to be used in this combination and obtain data on the combination's safety and activity profile.

Timeline

Start: 2001-12
Primary completion: 2005-01
Completion: 2007-05

Publications

Results Srokowski TP, Liebmann JE, Modiano MR, Cohen GI, Pro B, Romaguera JE, Kuepfer C, Singer JW, Fayad LE. Pixantrone dimaleate in combination with fludarabine, dexamethasone, and rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma: phase 1 study with a dose-expansion cohort. Cancer. 2011 Nov 15;117(22):5067-73. doi: 10.1002/cncr.26121. Epub 2011 Jun 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pixantrone	Small molecule	120 mg/m2	—
Background	Dexamethasone	Small molecule	—	—
Background	Fludarabine	Small molecule	—	—
Background	Rituximab	Monoclonal antibody	—	—

Dose Ranging Trial for Pixantrone in the FND-R Variant Regimen in Indolent Non-Hodgkin's Lymphoma

Summary

Timeline

Publications

Drugs

Indications