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Monoclonal Antibodies

Belimumab for Graft-versus-Host Disease

Phase 1
Waitlist Available
Led By Iskra Pusic, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after allohct
Awards & highlights

Study Summary

This trial is testing whether the drug belimumab is safe and effective in preventing chronic GvHD following allogeneic hematopoietic cell transplantation (alloHCT).

Who is the study for?
This trial is for adults over 18 with certain blood cancers who've had a bone marrow transplant and are in complete remission. They must have good organ function, no serious ongoing illnesses, not be on other investigational drugs or have recent infections, and agree to use contraception.Check my eligibility
What is being tested?
The trial tests Belimumab's ability to prevent chronic Graft-versus-Host Disease after stem cell transplants from matched donors. It aims to see if this drug can help control the immune response that sometimes attacks the patient's body after a transplant.See study design
What are the potential side effects?
Belimumab may cause allergic reactions due to its protein content, potential side effects related to immune system suppression such as increased risk of infection, and possibly other unknown risks since it’s under investigation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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I have been diagnosed with a blood cancer.
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I am undergoing a bone marrow preparation treatment.
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I will receive a stem cell transplant from a donor who is a complete HLA match.
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I am receiving methotrexate and tacrolimus to prevent graft-versus-host disease.
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My bone marrow transplant is successful and I am in complete remission.
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My liver and kidney functions are within the required range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after allohct
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after allohct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of belimumab as prophylaxis of chronic GvHD in subjects following alloHCT as measured by number of participants who experience each adverse event
Secondary outcome measures
Graft-vs-Host Disease
Graft-vs-Host Disease
Necessity to use alternative treatment modalities for chronic GvHD
+4 more

Side effects data

From 2018 Phase 3 trial • 80 Patients • NCT02119156
40%
Nasopharyngitis
10%
Upper respiratory tract infection bacterial
10%
Viral upper respiratory tract infection
10%
Viral myositis
10%
Musculoskeletal stiffness
10%
Intervertebral disc displacement
10%
Cataract
10%
Benign neoplasm of skin
10%
Adrenal insufficiency
10%
Myopathy
10%
Cystitis
10%
Upper respiratory tract infection
10%
Gastroenteritis
10%
Toothache
10%
Contusion
10%
Ocular discomfort
10%
Angular cheilitis
10%
Conjunctivitis
10%
Gingivitis
10%
Herpes zoster
10%
Osteoporosis
10%
Oropharyngeal pain
10%
Head injury
10%
Limb injury
10%
Back pain
10%
Polymyositis
10%
Stomatitis
10%
Abdominal discomfort
10%
Iron deficiency anaemia
10%
Chillblains
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Phase: Treatment Holiday
Treatment Phase: Treatment Holiday Group - Re-start Phase
Treatment Phase: Long-term Discontinuation Group
Treatment Phase: Treatment Control Group
Treatment Phase: Treatment Holiday Group - Holiday Phase
Maintenance Phase: Treatment Control

Trial Design

1Treatment groups
Experimental Treatment
Group I: BelimumabExperimental Treatment1 Intervention
Subjects meeting eligibility criteria will start treatment between Day +3- and Day +60 after alloHCT Belimumab will be administered intravenously every 2 weeks for 3 cycles and then every 4 weeks for a total of 7 cycles (6 months)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belimumab
2013
Completed Phase 4
~1840

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,202 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,742 Previous Clinical Trials
8,066,340 Total Patients Enrolled
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,447 Total Patients Enrolled

Media Library

Belimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03207958 — Phase 1
Graft-versus-Host Disease Research Study Groups: Belimumab
Graft-versus-Host Disease Clinical Trial 2023: Belimumab Highlights & Side Effects. Trial Name: NCT03207958 — Phase 1
Belimumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03207958 — Phase 1

Frequently Asked Questions

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

Does this research project currently accept new participants?

"At present, no participants are being sought for this experiment. It was initially posted on May 16th 2018 and subsequently updated in October 10th 2022. If you're interested in additional trials, 169 studies with related illnesses have open enrollment while 17 of those focus on the effects of Belimumab."

Answered by AI

How many participants will be enrolled in this clinical trial?

"Unfortunately, this trial has closed recruitment. It was initially released on May 16th 2018 and the last edit to its details occurred October 10th 2022. However, if you are interested in other trails there remain 169 studies searching for participants with related illness and 17 trials of Belimumab actively enrolling patients."

Answered by AI

Has this trial been undertaken before, or is it a pioneering effort?

"Presently, there are 17 ongoing Belimumab trials spanning 36 urban centres and 15 nations. The initial trial for this medication began in 2012 with Human Genome Sciences Inc., a GSK Company, as its sponsor; the Phase 2 stage was ended after 93 participants were included. Subsequent to that pioneering study, 38 additional experiments have been performed."

Answered by AI

Could you please elucidate the risk associated with Belimumab?

"Belimumab's safety and efficacy is not yet clinically established, resulting in an assigned score of 1."

Answered by AI

Are there any published accounts of Belimumab's effectiveness in previous research?

"Currently, 17 studies are underway to evaluate the efficacy of Belimumab. 2 of those experiments have reached Phase 3 and they're being conducted in Beijing as well as 88 other medical centres."

Answered by AI
~1 spots leftby Mar 2025