Conditions: Lymphoma
Keywords: Hodgkin Lymphoma Non-Hodgkin's Lymphoma Bone marrow transplant stem cell transplant busulfan cyclophosphamide etoposide
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 207
Healthy volunteers: no

Brief summary:
This is a study for the outcome and safety of individualized busulfan dosing with cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat Non-Hodgkin or Hodgkin's Lymphoma.

Detailed description:
Evaluation of progression-free survival, transplant related mortality, overall survival, and overall response rate, in subjects with NHL and HL receiving an IV busulfan-based conditioning regimen with PK-guided IV busulfan dosing, followed by autologous HSCT as well as comparison to those receiving carmustine, etoposide, cytarabine, and melphalan (BEAM) conditioning regimen (and its variants) obtained from registry data in the Center for International Blood and Marrow Transplant Research (CIBMTR) Assessment of the safety profile of a BuCyE conditioning regimen with PK-directed dosing of IV busulfan will also be completed.

Arms:
arm 1: Pk-directed IV Busulfan (based on test dose method) for 4 days followed by Etoposide 1400mg/m2 QD for one day and Cyclophosphamide 2.5 g/m2 QD for two days followed by autologous stem cell transplant

Interventions: intervention 1: IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)
Intervention descriptions: intervention 1: Pk-directed IV Busulfan (based on test dose method) for 4 days followed by Etoposide 1400mg/m2 QD for one day and Cyclophosphamide 2.5 g/m2 QD for two days followed by autologous stem cell transplant.

Protocol document: