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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

All Individual Drugs Already Approved

Approved for 20 Other Conditions

No Placebo-Only Group

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

quality of life

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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