drugset
drugset / Trial / NCT02589145

Lenalidomide Combined With Vorinostat/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Diffuse Large B-Cell Lymphoma of the ABC Subtype

NCT02589145 ↗

Phase 1/2 Terminated 8 enrolled M.D. Anderson Cancer Center Celgene Corporation · collab
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the highest tolerable dose of lenalidomide that can be given in combination 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 effectiveness of this combination.

Timeline

Start
2016-06-22
Primary completion
2019-04-08
Completion
2019-04-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 32 mg/m2 Intravenous
Subject Gemcitabine Small molecule 2775 mg Intravenous
Subject Lenalidomide Other / unclassified 50 mg Oral
Subject Melphalan Small molecule 60 mg/m2 Intravenous
Subject Vorinostat Small molecule 1000 mg Oral
Background Caphosol Other / unclassified 30 ml Oral
Background Dexamethasone Small molecule 8 mg Intravenous
Background Enoxaparin sodium Other / unclassified 40 mg Subcutaneous
Background Glutamine Other / unclassified 15 g Oral
Background Palifermin Protein / enzyme biologic — Intravenous
Background Pyridoxine Unknown 100 mg Intravenous
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications

lymphoma