CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Anti-thymocyte globulin (ATG) +4 moredrug
Likely dose
Anti-thymocyte globulin (ATG) 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/NCT03734601
NCT03734601Phase 2Completed
CompareCT.gov

Very Low-dose Total Body Irradiation in Combination With Total Lymphoid Irradiation and Anti-Thymocyte Globulin to Improve Donor Engraftment in Patients Undergoing Non-Myeloablative Hematopoietic Cell Transplantation

Stanford University·interventional·Posted Nov 8, 2018·Updated Dec 12, 2023

In Brief

A Phase 2 clinical trial evaluating Total body irradiation (TBI), Anti-thymocyte globulin (ATG), and 3 other interventions for Acute Myeloid Leukemia and 8 related conditions. Completed, enrolled 22 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Myelodysplastic Syndromes, Myeloproliferative Disorder, Chronic Lymphocytic Leukemia, B-cell Lymphoma, T-cell Lymphoma, Non Hodgkin Lymphoma, Hodgkin Lymphoma, Chronic Myelomonocytic Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 8, 2018
Enrollment StartNov 5, 2018
Primary CompletionDec 26, 2019
Study CompletionNov 17, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.6 years ago

Interventions

Total body irradiation (TBI)radiation

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

Anti-thymocyte globulin (ATG)drug

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

Tacrolimusdrug

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

Mycophenolate mofetil (MMF)drug

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.

Total lymphoid irradiation (TLI)radiation

9 x 120 cGy over 11 days