CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
ibritumomab tiuxetan +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00491491
NCT00491491Phase 3Completed
CompareCT.gov

SPINOZA / שפינוזה. Study With Preparatory INduction Of Zevalin in Aggressive Lymphoma. A Randomized Phase 3 Study of BEAM Versus 90Yttrium Ibritumomab Tiuxetan (Zevalin) / BEAM in Patients Requiring Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Relapsed Diffuse Large B-cell Lymphoma

Sheba Medical Center·interventional·Posted Jun 26, 2007·Updated Aug 31, 2020

In Brief

A Phase 3 clinical trial evaluating ibritumomab tiuxetan and BEAM chemotherapy and autologous stem-cell transplantation for Non-Hodgkin's Lymphoma. Completed, enrolled 60 participants across 9 sites in 4 countries.

Detailed Summary

The study hypothesis is that the addition of zevalin radioimmunotherapy to the conditioning regimen given prior to BEAM high-dose chemotherapy and autologous stem cell transplantation in patients with aggressive lymphoma will reduced disease recurrence rate and improve overall and disease-free survival.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma
CountriesGermany, Israel, Netherlands, United States
CollaboratorsCity of Hope Medical Center, Amsterdam UMC, location VUmc, University of Göttingen

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 26, 2007
Enrollment StartJun 1, 2007
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 19.0 years ago

Interventions

ibritumomab tiuxetandrug

0.4 mCi/kg

BEAM chemotherapy and autologous stem-cell transplantationprocedure