Tinostamustine Conditioning and Autologous Stem Cell

Summary

Phase 1 The primary objectives of Phase 1 of this study are to: * Establish the safety, toxicity, and maximum tolerated dose (MTD) of the tinostamustine conditioning regimen. * Identify the recommended Phase 2 dose (RP2D) of tinostamustine for use in the Phase 2 portion of the study. The secondary objective of Phase 1 of this study is to: \- Investigate the pharmacokinetics (PK) of tinostamustine.

Timeline

Start

2018-10-15

Primary completion

2019-04-17

Completion

2019-04-17

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision based on adverse events limiting administration of higher doses required to achieve myeoblative conditioning necessary in this population”

Drugs

Indications