drugset / Trial / NCT01983969

Aza-SAHA-GBM With AutoSCT for Refractory Lymphoma

NCT01983969

Phase 1/2 Completed 61 enrolled M.D. Anderson Cancer Center
SequentialOpen-labelTreatment

Summary

The goal of this clinical research study is to find the highest tolerable dose of azacitidine that can be given with vorinostat, gemcitabine, busulfan, and melphalan, with a stem cell transplant, and with or without rituximab. Researchers also want to learn about the safety and level of effectiveness of this combination.

Timeline

Start
2013-11-07
Primary completion
2017-11-22
Completion
2017-11-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 15 mg/m2 Intravenous
Subject Busulfan Small molecule 32 mg/m2 Intravenous
Subject Gemcitabine Small molecule 22775 mg/m2 Intravenous
Background Dexamethasone Small molecule 8 mg Intravenous
Background Glutamine Other / unclassified 15 g Oral
Background Melphalan Small molecule 60 mg/m2 Intravenous
Background Pyridoxine Unknown 100 mg Intravenous
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Vorinostat Small molecule 1000 mg Intravenous