CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalandrug
Likely dose
Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan 30mg/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/NCT01005576
NCT01005576Phase 2Completed
CompareCT.gov

A Pilot Trial of Unrelated Donor Hematopoietic Cell Transplantation for Children With Severe Thalassemia Using a Reduced Intensity Conditioning Regimen (The URTH Trial)

Washington University School of Medicine·interventional·Posted Nov 2, 2009·Updated Dec 13, 2017

In Brief

A Phase 2 clinical trial evaluating Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan for Severe Thalassemia. Completed, enrolled 21 participants across 18 sites.

Detailed Summary

This study is being done to determine if blood cell transplants, with either bone marrow or cord blood from unrelated donors, are effective in children with severe thalassemia and if this treatment approach has acceptable risks and side effects. This study includes a preparative regimen with Hydroxyurea, Alemtuzumab, Fludarabine, Thiotepa and Melphalan that provides intense host immunosuppression without myeloablation. The primary hypothesis is that this regimen will promote stable engraftment of unrelated donor hematopoietic cells, support normal erythropoiesis, and result in an event free survival of \> 75% of children with thalassemia major.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Thalassemia
CountriesUnited States
CollaboratorsCarelon Research, Pediatric Blood and Marrow Transplant Consortium

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2, 2009
Enrollment StartJan 1, 2010
Primary CompletionApr 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.7 years ago

Interventions

Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalandrug

Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion