CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Busulfan +2 moredrug
Likely dose
Busulfan 32 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/NCT00800839
NCT00800839Phase 2Completed

Busulfan (IV) and Fludarabine Followed by Post-allogeneic Transplantation Cyclophosphamide for Graft-versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies.

M.D. Anderson Cancer Center·interventional·Posted Dec 2, 2008·Updated Sep 19, 2016

In Brief

A Phase 2 clinical trial evaluating Busulfan, Fludarabine, and 1 other intervention for Hematologic Diseases and 3 related conditions. Completed, enrolled 56 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if cyclophosphamide given after busulfan and fludarabine can help to prevent graft versus host disease (GVHD - a condition in which transplanted tissue attacks the body into which it is transplanted) in patients receiving a stem cell transplant. The safety of this drug combination will also be studied.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2008
Enrollment StartSep 1, 2008
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 17.6 years ago

Interventions

Busulfandrug

Starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3.

Fludarabinedrug

Dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan.

Cyclophosphamidedrug

Dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.