Tacrolimus for Graft-versus-Host Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Graft-versus-Host Disease+2 MoreTacrolimus - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 1 year post HCT

1 year post HCT
Chronic Graft-versus Host Disease Through 1 Year Post HCT
Glucocorticoid Exposure
Incidence of Grade II-IV Acute Graft-versus Host Disease
Malignancy Relapse Post-HCT
Neutrophil and Platelet Engraftment
Non-relapse Mortality
Overall Survival (OS)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Combination Therapy
1 of 1

Experimental Treatment

36 Total Participants · 1 Treatment Group

Primary Treatment: Tacrolimus · No Placebo Group · Phase 1

Combination TherapyExperimental Group · 3 Interventions: Tacrolimus, Sirolimus, BMS-986004 · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
FDA approved
Sirolimus
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year post hct

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
503 Previous Clinical Trials
125,953 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,500 Previous Clinical Trials
3,927,486 Total Patients Enrolled
Farhad Khimani, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a hematologic malignancy or blood disorder requiring allogeneic HCT.
You have a KPS score of 80% or higher.