CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 82 enrolled
Drug / intervention
Busulfan +1 moredrug
Likely dose
Busulfan 0.8 mg/kgfrom 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/NCT00506857
NCT00506857Phase 2Completed
CompareCT.gov

Phase I/II Trial of Fludarabine in Combination With Intravenous Busulfan and Allogeneic Progenitor Cell Support for Patients With Hematologic Malignancies

M.D. Anderson Cancer Center·interventional·Posted Jul 25, 2007·Updated Feb 28, 2012

In Brief

A Phase 2 clinical trial evaluating Busulfan and Fludarabine for Hematologic Malignancies. Completed, enrolled 82 participants across 1 site.

Detailed Summary

Objectives: 1. To determine the relative toxicities, engraftment potential, kinetics of engraftment, degree of chimerism and disease control achieved with the combination of fludarabine and busulfan at different dose levels and different dose schedules in patients undergoing allogeneic stem cell transplant (SCT). 2. Determine pharmacokinetics, and toxicity of intravenous busulfan given at equal total dose levels given four times daily, or once daily. 3. In vivo determination of fludarabine inhibitory effects on DNA repair.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematologic Malignancies
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2007
Enrollment StartNov 1, 2003
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 18.9 years ago

Interventions

Busulfandrug

Starting Dose 0.8 mg/kg by vein every 6 hours x 12 doses.

Fludarabinedrug

30 mg/m\^2 by vein daily x 4 days.