Gemcitabine Plus Busulfan, Melphalan and Hematopoietic Cell Transplant for Advanced Lymphoid Malignancies

Phase 1 Completed 145 enrolled M.D. Anderson Cancer Center

NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the highest tolerated dose of gemcitabine that can be given with busulfan and melphalan. The safety of this drug combination will also be studied.

Timeline

Start: 2006-12
Primary completion: 2012-09
Completion: 2012-09

Publications

Nieto Y, Gruschkus S, Valdez BC, Jones RB, Anderlini P, Hosing C, Popat U, Qazilbash M, Kebriaei P, Alousi A, Saini N, Srour S, Rezvani K, Ramdial J, Barnett M, Gulbis A, Shigle TL, Ahmed S, Iyer S, Lee H, Nair R, Parmar S, Steiner R, Dabaja B, Pinnix C, Gunther J, Cuglievan B, Mahadeo K, Khazal S, Chuang H, Champlin R, Shpall EJ, Andersson BS. Improved outcomes of high-risk relapsed Hodgkin lymphoma patients after high-dose chemotherapy: a 15-year analysis. Haematologica. 2022 Apr 1;107(4):899-908. doi: 10.3324/haematol.2021.278311.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Busulfan	Small molecule	105 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	75 mg/m2	Intravenous
Subject	Melphalan	Small molecule	60 mg/m2	Intravenous
Background	Palifermin	Protein / enzyme biologic	60 ug/kg	Intravenous
Background	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous

Gemcitabine Plus Busulfan, Melphalan and Hematopoietic Cell Transplant for Advanced Lymphoid Malignancies

Summary

Timeline

Publications

Drugs

Indications