CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Thymoglobulin +4 morebiological
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/NCT00709592
NCT00709592Phase 2Completed
CompareCT.gov

Reduced Intensity Myeloablative Total Body Irradiation and Thymoglobulin Followed by Allogeneic Peripheral Blood Stem Cell Transplantation

Virginia Commonwealth University·interventional·Posted Jul 3, 2008·Updated Nov 9, 2018

In Brief

A Phase 2 clinical trial evaluating Thymoglobulin, Total-Body Irradiation, and 3 other interventions for Non-Hodgkin's Lymphoma and 7 related conditions. Completed, enrolled 42 participants across 1 site.

Detailed Summary

One of two different doses of thymoglobulin will allow bone marrow engraftment with minimal Graft-versus-Host Disease and allow adequate immune response to allow the transplanted stem cells to replace the tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma, Leukemia, Multiple Myeloma, Acute Myeloid Leukemia, Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome
CountriesUnited States
CollaboratorsGenzyme, a Sanofi Company

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 3, 2008
Enrollment StartJul 21, 2008
Primary CompletionFeb 15, 2014
Study CompletionJun 28, 2017
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 18.0 years ago

Interventions

Thymoglobulinbiological

Patients eligible for participation in this study will be randomized between receiving rabbit ATG for 3 days. Thymoglobulin will be administered according to VCU BMT standard of care starting day -9 and continued daily through day -7.

Total-Body Irradiationradiation

Undergo TBI

Allogeneic PBSCT or BMTprocedure

Undergo allogeneic PBSCT or BMT

Tacrolimusdrug

Given PO

Mycophenolate Mofetildrug

Given PO