At a glance
ClinicalIndex Comparison Record- ✓Histologically proven diffuse large B-cell lymphoma (CD20 positive) or transformed follicular non-Hodgkin's lymphoma that has relapsed after conventional chemotherapy
- ✓Chemosensitive disease to salvage chemotherapy
- ✓Less than 5% bone marrow involvement with lymphoma
- ✓Age ≤80 years
- ✕Active CNS disease
- ✕Prior history of CNS disease without documented negative MRI (brain/spine if indicated) and negative CSF cytology within 4 weeks
- ✕Less than 3 weeks from last cytotoxic chemotherapy
- ✕Serum bilirubin >1.5 mg/dL
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Trial Using Standard Dose Versus High Dose Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Diffuse Large B Cell Lymphomas
In Brief
A Phase 2 clinical trial evaluating Carmustine, Etoposide, and 3 other interventions for Lymphoma. Completed, enrolled 93 participants across 1 site.
Detailed 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)
Study Details
Timeline
Interventions
300 mg/m\^2 IV for 1 Day
Arm 1 = 200 mg/m\^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m\^2 IV Every 12 Hours x 4 Days
Arm 1 = 200 mg/m\^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m\^2 IV Every 12 Hours x 4 Days
140 mg/m\^2 IV x 1 Day
Cohort 1, High-Dose Rituximab = 1000 mg/m\^2 IV On Days +1 and +8 After Stem Cell Infusion; Cohort 2, Standard Dose Rituximab = 375 mg/m\^2 IV On Days +1 and +8 After Stem Cell Infusion.