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Immunosuppressant

Tacrolimus for Graft-versus-Host Disease

Phase 1

Waitlist Available

Led By Farhad Khimani, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post hct

Awards & highlights

Study Summary

This trial will study whether the addition of BMS-986004 to standard of care Sirolimus-based immunosuppression is safe and effective.

Eligible Conditions

Graft-versus-Host Disease
Acute Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post hct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post hct

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post hct for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of Grade II-IV Acute Graft-versus Host Disease

Secondary outcome measures

Chronic Graft-versus Host Disease Through 1 Year Post HCT

Malignancy Relapse Post-HCT

Non-relapse Mortality

+1 more

Other outcome measures

Glucocorticoid Exposure

Neutrophil and Platelet Engraftment

Trial Design

1Treatment groups

Experimental Treatment

Group I: Combination TherapyExperimental Treatment3 Interventions

BMS-986004: From day 13, intravenously (IV) every 2 week through day 100 post HCT. Tacrolimus: From day -3 as standard of care. Sirolimus: From day -1 as standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tacrolimus

2011

Completed Phase 4

~4740

Sirolimus

2013

Completed Phase 4

~2750

BMS-986004

2019

Completed Phase 1

~50

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,447 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,469 Total Patients Enrolled

Farhad Khimani, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

Frequently Asked Questions

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

What is the current number of individuals engaged in this experiment?

"Correct. Clinicaltrials.gov records show that this investigation is presently recruiting, having initially been posted on February 15th 2019 and most recently updated on July 27th 2022. The team seeks to enroll 36 individuals across 3 locations for the study."

Answered by AI

What prior research exists surrounding the efficacy of Tacrolimus?

"Presently, 256 clinical trials are actively investigating the use of Tacrolimus with 29 in advanced Phase 3. Across these studies, 1697 locations have been recruited to participate with several located within Philadelphia Pennsylvania."

Answered by AI

How hazardous is Tacrolimus for human health?

"Tacrolimus has only been tested minimally, so it receives a score of 1. This is the lowest rating on our scale and implies limited data regarding safety and efficacy."

Answered by AI

What illnesses are alleviated with Tacrolimus?

"Tacrolimus is frequently utilized for patients undergoing organ transplants, yet it can also prove advantageous in treating afflictions such as skin inflammation, allergic reactions, liver and kidney transplant rejections."

Answered by AI

Are there any vacancies available to partake in this trial?

"The information hosted on clinicaltrials.gov shows that this medical trial is actively in search of participants. It was originally published on February 15th 2019 and its most recent update occurred on July 27th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease

2019. "CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03605927.