CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Y Zevalin +8 moredrug
Likely dose
Rituxan 250 mg/m2from 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/NCT01538472
NCT01538472Phase 2Completed
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Y Zevalin, BEAM and Rituximab In Autologous Stem Cell Transplantation (ASCT) For Lymphoma

M.D. Anderson Cancer Center·interventional·Posted Feb 24, 2012·Updated Sep 11, 2014

In Brief

A Phase 2 clinical trial evaluating Y Zevalin, In Zevalin, and 7 other interventions for Lymphoma. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to see if high-dose chemotherapy (BEAM) and rituximab, given together with the new drug 90Y Zevalin, followed by a transplant of blood or marrow stem cells is safe. Another goal is to learn if this treatment can help decrease the chances of the cancer coming back.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States
CollaboratorsBiogen

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 24, 2012
Enrollment StartSep 1, 2003
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 14.4 years ago

Interventions

Y Zevalindrug

Starting dose: 0.4 mCi/kg by vein after Rituxan infusion on Day -14.

In Zevalindrug

Imaging dose: 5 mCi by vein following Rituxan infusion on Day -21.

Rituxandrug

250 mg/m2 by vein on Day -21 and on Day -14. 1000 mg/m2 by vein on Days +1 and +8.

BCNUdrug

300 mg/m2 by vein on Day -6.

VP -16drug

200 mg/m2 by vein every 12 hours on Days -5, -4, -3, and -2.

Ara-Cdrug

200 mg/m2 by vein every 12 hours on Days -5, -4, -3,and -2.

Melphalandrug

140 mg/m2 by vein on Day -1.

Stem Cell Infusionprocedure

Autologous stem cell infusion on Day 0.

G-CSFdrug

5 mg/kg by vein daily starting Day 0 till recovery of granulocytes of 4.0 x 109/L.