CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Thymoglobulin +3 moredrug
Likely dose
Thymoglobulin 1.5 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/NCT00476229
NCT00476229N/ACompleted

Total Lymphoid Irradiation, Thymoglobulin, and Rituximab for Allogeneic Transplantation in Lymphoid Malignancies

M.D. Anderson Cancer Center·interventional·Posted May 21, 2007·Updated Aug 7, 2012

In Brief

A clinical study evaluating Thymoglobulin, Total Lymphoid Irradiation, and 2 other interventions for Lymphoma and Leukemia. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Primary Objective: 1\. To determine whether the primary endpoint: the composite success rate, defined as the proportion of patients who are alive at day 100; and are without grade 3-4 Graft versus Host Disease (GVHD); and are without grade 4 toxicity (unrelated to infection); and have engrafted, is likely to be at least 40%. Secondary Objectives: 1. To determine the cumulative incidence of chronic graft versus host disease. 2. To determine the overall and disease free survival.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Leukemia
CountriesUnited States

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 21, 2007
Enrollment StartJun 1, 2006
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 19.1 years ago

Interventions

Thymoglobulindrug

1.5 mg/kg by vein on Days -11 to -7.

Total Lymphoid Irradiationradiation

80 cGy daily on days -11 to -7 and -4 to 0.

Peripheral Blood Stem Cell Infusionprocedure

PBSC infusion administered on day 0.

Rituximabdrug

375 mg/m\^2 by vein on days -13, -6, 1, \& 8. Only those patients whose tumors express CD20 will receive Rituximab.