NCT03734601

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

Primary Objective: • Determine the proportion of patients with full donor T-cell chimerism at Day 28 following hematopoietic cell transplantation. Secondary Objectives: * Determine the risk of disease progression, overall and event free survival, and non-relapse mortality, following treatment with TLI; ATG; and TBI. * Determine the incidence of acute and chronic GVHD following treatment with TLI; ATG; and TBI. Exploratory Objectives: • Determine the changes in frequency of hematopoietic stem, progenitor, and mature cell subsets and the changes in cytokine milieu and cellular architecture in the bone marrow of patients receiving TLI compared to TLI+TBI.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes
• Myeloproliferative Disorder
• Chronic Lymphocytic Leukemia
• B-cell Lymphoma
• T-cell Lymphoma
• Non Hodgkin Lymphoma
• Hodgkin Lymphoma
• Chronic Myelomonocytic Leukemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-11-05
• Primary completion: 2019-12-26
• Completion: 2020-11-17
• First posted: 2018-11-08
• Last updated: 2023-12-12
• Results posted: 2021-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study