drugset / Trial / NCT02701673

Belinostat Combined With Azacitidine/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Refractory or Relapsed Lymphoma

NCT02701673

Phase 1/2 Withdrawn M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the highest tolerable dose of belinostat that can be given in combination with azacitidine, gemcitabine, busulfan, and melphalan to patients who are scheduled to have a stem cell transplant. If you have diffuse large B-cell lymphoma (DLBCL), you will also receive rituximab. Researchers also want to learn about the safety and effectiveness of this combination.

Timeline

Start
2016-06
Primary completion
2019-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 15 mg/m2 Intravenous
Subject Belinostat Small molecule 100 mg/m2 Intravenous
Subject Busulfan Small molecule 32 mg/m2 Intravenous
Subject Gemcitabine Small molecule 75 mg/m2 Intravenous
Subject Melphalan Small molecule 60 mg/m2 Intravenous
Background Caphosol Other / unclassified 30 ml Oral
Background Glutamine Other / unclassified 15 g Oral
Background Pyridoxine Unknown 100 mg Intravenous

Indications