CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Clofarabine/Busulfan x 4 +2 moredrug
Likely dose
Clofarabine/Busulfan x 4 20 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/NCT00556452
NCT00556452Phase 2Completed
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Phase I/II Study of Myeloablative Allogeneic Stem Cell Transplantation for Aggressive Hematologic Malignancies Using Clofarabine and Busulfan x 4 (Clo/BU4) Regimen

University of Michigan Rogel Cancer Center·interventional·Posted Nov 12, 2007·Updated Dec 5, 2017

In Brief

A Phase 2 clinical trial evaluating Clofarabine/Busulfan x 4, Peripheral blood stem cell transplant, and 1 other intervention for Leukemia and 4 related conditions. Completed, enrolled 46 participants across 1 site.

Detailed Summary

The goals of the study are (Phase I) to determine the appropriate dose for Clofarabine with Busulfan as a full-intensity conditioning (Clo/BU4 regimen) prior to transplant and then (Phase II) to investigate the safety and effectiveness of this regimen as a conditioning for stem cell transplant in the treatment of aggressive hematologic malignancies in subjects where more conventional approaches are failing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome
CountriesUnited States
CollaboratorsGenzyme, a Sanofi Company

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 12, 2007
Enrollment StartOct 1, 2007
Primary CompletionJun 1, 2011
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 18.6 years ago

Interventions

Clofarabine/Busulfan x 4drug

Clofarabine IV (dose levels) * 1st dose level: 20 mg/m2/day x 5 days * 2nd dose level: 30 mg/m2/day x 5 days * 3rd dose level: 40 mg/m2/day x 5 days Busulfan IV 3.2 mg/kg daily x 4 days

Peripheral blood stem cell transplantprocedure

Peripheral blood stem cell transplant, after pre-conditioning drug treatment

Total Lymphoid Irradiationradiation

Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant