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Immunosuppressant

High Dose Thymoglobulin for Graft-versus-Host Disease Prophylaxis (ATG2017 Trial)

Phase 2

Recruiting

Led By Jan Storek, MD

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

First allogeneic HCT, performed for a hematologic malignancy, using filgrastim-mobilized peripheral blood stem cells (PBSC). Conditioning with fludarabine 50 mg/m2 daily on day -6 to -2, busulfan approximately 3.2 mg/kg daily on day -5 to -2 with PK adjustment (target AUC of 3750 uM*min/L) and total body irradiation (TBI) 2 Gy x 2 given typically on day -1 and/or day 0 (before graft infusion), ie, our standard myeloablative conditioning. Dose and schedule adjustments per Investigator discretion are permitted. Planned GVHD prophylaxis with our standard of low-dose ATG (4.5 mg/kg) + MTX + high-dose CSA. HLA matched sibling donor, or ≥7/8 HLA allele-matched unrelated donor (maximum 1 allele mismatch at HLA-A, B, C, or DRB1). Age >17 years.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

ATG2017 Trial Summary

This trial will compare two different doses of ATG (a medication used to prepare the body for a stem cell transplant) to see which is more effective in preventing transplant complications.

Who is the study for?

This trial is for adults over 17 who need their first blood stem cell transplant due to a blood cancer. They must have an HLA matched sibling or almost fully matched unrelated donor, and meet specific health criteria like normal liver function tests. People with previous transplants, certain infections (HIV, high-risk CMV), contact with tuberculosis, severe obesity, or women who are pregnant/breastfeeding or not using contraception can't join.Check my eligibility

What is being tested?

The study compares two approaches to prevent graft-versus-host disease after a stem cell transplant: the usual low dose of Thymoglobulin plus standard drugs versus a high dose of Thymoglobulin with a lower dose of these drugs. The goal is to see if the higher Thymoglobulin dose better prevents relapse and chronic disease without increasing other complications.See study design

What are the potential side effects?

Thymoglobulin may cause reactions such as fever and chills during infusion, increase infection risk due to immune suppression, cause liver enzyme changes indicating potential liver damage, and possibly lead to allergic reactions in those sensitive to rabbit proteins.

ATG2017 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 17 and getting my first stem cell transplant for blood cancer with a specific treatment plan.

ATG2017 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

moderate/severe chronic GVHD- and relapse-free survival (cGFRS) at 2 years post transplant

Secondary outcome measures

quality of life

ATG2017 Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment Arm - High dose ATG, Low dose CSAExperimental Treatment1 Intervention

High dose ATG will be infused on days -4, -3, -2, -1 and 0. Before each infusion of ATG (thymoglobulin), patient will receive medications preventing side effects from the ATG, including diphenhydramine (Benadryl), an antipyretic (ibuprofen or acetaminophen) and methylprednisolone (Solumedrol). The high dose ATG will be given into patient's vein via central venous catheter. Each infusion of ATG will take 4-8 hours. CSA (cyclosporine A) will be given from day 21. Standard dose methotrexate will be given.

Group II: Control Arm - Standard of careExperimental Treatment1 Intervention

Low dose ATG (thymoglobulin) will be infused on days -2, -1 and 0, and CSA (cyclosporine A) will be given from day -1 through day 84. Standard dose methotrexate will also be given.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor

182 Previous Clinical Trials

36,012 Total Patients Enrolled

Jan Storek, MDPrincipal InvestigatorTom Baker Cancer Centre

Media Library

Thymoglobulin (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT03456817 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How has the risk profile of high dose ATG been evaluated in this particular treatment arm?

"Treatment Arm - high dose ATG has been evaluated with a 2, as this is considered to be a Phase 2 trial. Although there's data that suggests safety, efficacy of the treatment remains unconfirmed."

Answered by AI

Is recruitment for this research endeavor still available?

"Affirmative. According to the clinicaltrials.gov website, this trial is open and inviting participants who meet certain criteria to join. It was first posted on July 1st 2020 with an update as recent as October 14th 2022 - 200 people are required at a single medical centre in order for the study to move forward."

Answered by AI

How many participants are eligible to join this research investigation?

"Indeed, clinicaltrials.gov states that this medical study is actively recruiting patients after first being posted on July 1st 2020 and most recently edited on October 14th 2022. 200 participants are being sought from one location for the trial."

Answered by AI

What medical conditions are most commonly treated with the high dose ATG Therapy Protocol?

"The high dose ATG treatment arm is commonly used for transplantation, but it has shown efficacy with a variety of medical issues such as lupus nephritis, excessive tearing, and bulla."

Answered by AI

Are there other studies that have evaluated the efficacy of high dose ATG as part of Treatment Arm?

"Currently, 67 trials for Treatment Arm - high dose ATG are in progress. 12 of these studies have reached Phase 3 and 470 clinical trial locations offer this treatment regimen. Specifically, some sites that provide the medication are located in Aurora, Colorado."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "HIgh Dose Thymoglobulin Instead of Cyclosporine With a Low Dose of Thymoglobulin for GVHD Prophylaxis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03456817.

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