CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Bortezomib +1 moredrug
Likely dose
Bortezomib 1.5 mgfrom 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/NCT00571493
NCT00571493Phase 2Completed
CompareCT.gov

Phase I/II Study of VELCADE®-BEAM and Autologous Hematopoietic Stem Cell Transplantation for Relapsed Indolent Non-Hodgkin's Lymphoma, Transformed or Mantle Cell Lymphoma

University of Nebraska·interventional·Posted Dec 12, 2007·Updated Sep 28, 2023

In Brief

A Phase 2 clinical trial evaluating Bortezomib and BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) for Non-hodgkin's Lymphoma and Mantle Cell Lymphoma. Completed, enrolled 42 participants across 1 site.

Detailed Summary

This is a Phase I/II trial designed to study the toxicity and Maximum Tolerated Dose (MTD) of bortezomib in combination with BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) and autologous hematopoietic stem cell transplantation (ASCT) and to obtain a preliminary estimate of the response rate to this combination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-hodgkin's Lymphoma, Mantle Cell Lymphoma
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 12, 2007
Enrollment StartApr 14, 2006
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 18.6 years ago

Interventions

Bortezomibdrug

Patients will receive bortezomib in four dose cohorts ( .8. 1.0, 1.3, 1.5 mg/m²). Patients will receive bortezomib on days -11, -8, -5, and -2 before infusion of autologous stem cells.

BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan)drug

All study patients will receive BEAM per the standard institution protocol: BCNU (carmustine): 300 mg/m²on day -5 etoposide 100 mg/m² twice daily on days -5, -4, -3, and -2 cytarabine 100 mg/m² twice daily on days -5, -4, -3, -2 melphalan: 140 mg/m² on day -1 before infusion of autologous stem cells.