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Antibody

Intervention arm for Graft-versus-Host Disease

Phase 2
Waitlist Available
Led By Jan Storek, MD, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
First allogeneic hematopoietic cell transplantation (second transplants are rare, typically performed for relapse of leukemia, in which case the likelihood of relapse is high, and there is the theoretical risk of increasing the likelihood further with ATG).
Conditioning including ATG 4.5 mg/kg (the predictive value of IL15 and IL2Ra levels was determined in patients whose conditioning included 4.5 mg/kg or ATG).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

Graft-vs-host disease (GVHD) causes substantial mortality, morbidity and poor quality of life after blood or marrow transplantation (BMT). In Alberta, we use antithymocyte globulin (ATG, given on days -2, -1 and 0) in addition to methotrexate and cyclosporine for GVHD prophylaxis. In spite of that, ~40% patients develop significant GVHD (grade 2-4 acute GVHD or chronic GVHD needing systemic immunosuppressive therapy). ATG at the dose we typically use (4.5 mg/kg) is relatively non-toxic. At higher doses, ATG could increase the likelihood of posttransplant infections or relapse. Thus an extra dose of ATG (on top of the routine 4.5 mg/kg) might be justified only for patients at high risk of developing significant GVHD. In our experience, low serum level of interleukin-15 (IL15) and high serum level of interleukin-2 receptor alpha (IL2Ra) on day 7 predict development of significant GVHD. Here we will test whether, compared to historical/concurrent controls, an extra dose of ATG (3 mg/kg on day 8) given to patients with low IL15 or high IL2Ra on day 7 reduces the incidence of significant GVHD, and improves survival free of relapse and GVHD, and quality of life.

Eligible Conditions
  • Graft-versus-Host Disease

Eligibility Criteria

Inclusion Criteria

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

Timeline

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
Cumulative incidence of significant GVHD
Secondary outcome measures
Quality of life measured by SF36
Survival free of relapse and significant GVHD

Side effects data

From 2019 Phase 4 trial • 316 Patients • NCT01729494
57%
Hematologic events
48%
Gastrointestinal events
35%
Nephrotoxicity events
31%
Neurologic events
30%
Electrolyte/metabolic events
27%
Renal dysfunction resulting in hospitalization
22%
Infection Requiring Hospitalization
14%
Leukopenia WBC < 2000/mm3
12%
Nausea/vomiting or GI requiring hospitalization
9%
Wound healing
7%
Malignancy
6%
Anemia (Hg < 7gm/dL)
5%
Musculoskeletal/Bone events
5%
Mental status changes or neurological AE's
3%
Cardiovascular event
1%
Thrombocytopenia (PLT < 50,000/mm3)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group C
Group B
Group A

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intervention armExperimental Treatment1 Intervention
Transplant recipients will have IL15 and IL2Ra measured on day 7. If at risk for significant GVHD, the patient will get rabbit antithymocyte globulin, 3 mg/kg on day 8. Patients from this intervention/experimental arm will be compared to historical and concurrent controls (no ATG on day 8).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antithymocyte immunoglobulin (rabbit)
FDA approved

Find a Location

Who is running the clinical trial?

University of AlbertaOTHER
883 Previous Clinical Trials
393,139 Total Patients Enrolled
University of CalgaryLead Sponsor
780 Previous Clinical Trials
841,664 Total Patients Enrolled
Alberta Health servicesOTHER
156 Previous Clinical Trials
647,711 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Mar 2025