HIgh Dose Thymoglobulin Instead of Cyclosporine With a Low Dose of Thymoglobulin for GVHD Prophylaxis — ATG2017  

Relapse Clinical Trial

Official title: A Phase 2, Open-label Study to Evaluate Graft-vs-host Disease Prophylaxis With High Dose Thymoglobulin, Methotrexate, and Low-dose Cyclosporine in Comparison to Historical/Concurrent Controls Who Received Low Dose Thymoglobulin, Methotrexate, and High-dose Cyclosporine

Status Recruiting

Clinical Trial Summary

The purpose of this study is to find out whether compared to our standard low dose ATG with CSA, the high dose ATG with low-dose CSA minimizes the chances of relapse and chronic GVHD, without increasing the chances of other transplant complications.

Clinical Trial Description

There are a number of complications of allogeneic hematopoietic cell transplantation.

The main complications are:

• Relapse (leukemia or leukemia-like disease returning). This usually leads to death.

• Acute graft-versus-host disease (GVHD). This may lead to death.

• Chronic GVHD. This may lead to poor quality of life long-term.

This study is being done to minimize the chances of patients getting relapse and chronic GVHD, without increasing the chances of getting acute GVHD.

At this time, the standard of care approach to treat this condition would be with:

• Low dose thymoglobulin (ATG), given on Day -2, -1 and 0.

• Cyclosporin (CSA), given from Day -1 through to Day 84.

• Methotrexate, given on Days 1, 3, 6 and 11

CSA reduces the chances of getting acute GVHD, but it does not reduce the chances of getting chronic GVHD and increases the chances of getting relapse. ATG reduces both acute and chronic GVHD, and does not increase relapse.

In this study, high dose ATG will be given on days -4, -3, -2, -1 and 0 (instead of only on days -2, -1 and 0), CSA will be given only from day 21 through 84 (instead of from day -1 through 84), and the routine dose of methotrexate (unchanged) will be given. We think that this may lead to better outcomes.

Patients will be followed per standard practice of the Alberta Blood and Marrow Transplant Program for the development of acute and chronic GVHD, and for relapse.

Patients will also be asked to complete a quality of life questionnaire 2 years after the transplant to assess how their treatment and illness affects their quality of life. ;

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-versus-host-disease
• Relapse

• NCT number: NCT03456817
• Study type: Interventional
• Source: AHS Cancer Control Alberta
• Contact: Jan Storek, MD
• Phone: 403-210-8630
• Email: jstorek@ucalgary.ca
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2020
• Completion date: September 2025