drugset / Trial / NCT00472056

Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies

NCT00472056

Phase 2 Completed 93 enrolled M.D. Anderson Cancer Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Cohort 1: Patients who are less than or equal to 65 years of age. 1\. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab) Cohort 2: Patients who are older than 65 years of age 1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab) 2. To determine the treatment related mortality (TRM)

Timeline

Start
2005-03
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 100 mg/m2
Subject Cytarabine Small molecule 200 mg/m2
Subject Etoposide Small molecule 100 mg/m2
Subject Etoposide Small molecule 200 mg/m2
Subject Melphalan Small molecule 140 mg/m2
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 1000 mg/m2 Intravenous
Subject carmustine Small molecule 300 mg/m2

Indications