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Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation

NCT03734601 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-12-12

Study results available
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Summary

The purpose of this study is to evaluate whether addition of a low dose of total body irradiation (TBI) to a standard preparation for transplant \[total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG)\] conditioning will help to augment donor chimerism without reducing tolerability of this regimen or increasing the risk of graft-vs-host disease (GVHD)

Conditions

Interventions

RADIATION

Total body irradiation (TBI)

Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning

DRUG

Anti-thymocyte globulin (ATG)

Given intravenous (IV), Dose 1.5 mg/kg x 5 days

DRUG

Tacrolimus

Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV)

DRUG

Mycophenolate mofetil (MMF)

Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors.

RADIATION

Total lymphoid irradiation (TLI)

9 x 120 cGy over 11 days

Sponsors & Collaborators

Principal Investigators

  • Robert Lowsky, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2019-12-26
Completion
2020-11-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03734601 on ClinicalTrials.gov