CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
Bortezomib with mitoxantrone, etoposide and cytarabine +2 moredrug
Likely dose
Bortezomib 1.0mg/m^2from 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/NCT00410423
NCT00410423Phase 2Completed
CompareCT.gov

Phase I/II Trial of VELCADE® (Bortezomib) in Combination With Mitoxantrone and Etoposide for Relapsed or Refractory Acute Leukemias

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·interventional·Posted Dec 12, 2006·Updated Apr 30, 2025

In Brief

A Phase 2 clinical trial evaluating Bortezomib with mitoxantrone, etoposide and cytarabine, Bortezomib 1.0mg/m^2, and 1 other intervention for Relapsed Acute Leukemia and Refractory Acute Leukemia. Completed, enrolled 55 participants across 1 site.

Detailed Summary

Based on what is known about it's mechanism of action, bortezomib is presumed to make other chemotherapy drugs work better. This study examines the use of bortezomib in combination with an already effective chemotherapy regimen that is used to treat leukemias that have relapsed or been refractory to treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed Acute Leukemia, Refractory Acute Leukemia
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 12, 2006
Enrollment StartJan 1, 2006
Primary CompletionMay 1, 2013
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 19.6 years ago

Interventions

Bortezomib with mitoxantrone, etoposide and cytarabinedrug

All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.

Bortezomib 1.0mg/m^2drug

All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.

Bortezomib 1.3mg/m^2drug

All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.