CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Intrabone cord blood infusionprocedure
Likely dose
Not stated in 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/NCT00886522
NCT00886522Phase 2Completed

Intrabone Infusion of Cord Blood Hemopoietic Stem Cells in Adult Patients With High Risk Haematological Malignancies.

IRCCS Azienda Ospedaliero-Universitaria di Bologna·interventional·Posted Apr 23, 2009·Updated Mar 19, 2021

In Brief

A Phase 2 clinical trial evaluating Intrabone cord blood infusion for Hematological Malignancies. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the engraftment of donor hemopoiesis (proportion of transplanted patients with successful engraftment at day +42) in adult patients affected by high risk hematological malignancies after intrabone infusion of cord blood.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 23, 2009
Enrollment StartApr 1, 2009
Primary CompletionMay 1, 2012
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.2 years ago

Interventions

Intrabone cord blood infusionprocedure

Myeloablative conditioning regimen (MAC): i.v. Busulfan 12.8 mg/kg, Cyclophosphamide 120 mg/kg, ATG-Fresenius 30 mg/kg Reduced intensity conditioning regimen (RIC): Tiothepa 10 mg/kg, Fludarabine 100 mg/kg, Cyclophosphamide 100 mg/kg, ATG-Fresenius 30 mg/kg GVHD prophylaxis: Cyclosporine 1 mg/kg since day -7 to +120, Mycophenolate 15 mg kg x 2 since day +1 to +27