Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration Tacrolimus for Graft-versus-Host Disease

NYU Langone Health, New York, NY
Graft-versus-Host DiseaseAbatacept - Drug
Eligibility
18 - 100
All Sexes

Study Summary

This trial tests an experimental treatment using reduced cyclophosphamide, abatacept, and tacrolimus to prevent GvHD in adult patients with hematological malignancies undergoing allogeneic HSCT.

Eligible Conditions
  • Graft-versus-Host Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to Day 730

Up to Day 120
Cumulative Incidence of Grades II-IV Acute GvHD
Up to Day 30
Number of Participants Presenting with Poor Graft Function
Up to Day 365
Cumulative Incidence of Chronic GvHD
Up to Day 45
Number of Participants Presenting with Primary Graft Failure
Up to Day 730
GvHD and Relapse-Free Survival (GRFS) Rate
Number of Participants Presenting with Secondary Graft Failure
Overall Survival (OS) Rate
Relapse Rate (RR)
Treatment-Related Mortality (TRM) Rate

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration Tac...
1 of 1

Experimental Treatment

92 Total Participants · 1 Treatment Group

Primary Treatment: Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration Tacrolimus · No Placebo Group · Phase 2

Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration TacrolimusExperimental Group · 3 Interventions: Abatacept, Tacrolimus, Cyclophosphamide · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abatacept
2005
Completed Phase 4
~111470
Tacrolimus
2011
Completed Phase 4
~4510
Cyclophosphamide
1995
Completed Phase 3
~3920

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to day 730

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,306 Previous Clinical Trials
761,694 Total Patients Enrolled
Jaime Suarez LondonoPrincipal InvestigatorNYU Langone Medical Center

Eligibility Criteria

Age 18 - 100 · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

Are there any remaining openings in this medical trial?

"According to information presented on clinicaltrials.gov this experiment is in the recruitment phase of its cycle. The trial was initially announced on August 23rd 2022 and its most recent update occurred November 10th 2022." - Anonymous Online Contributor

Unverified Answer

Is there an age cap for enrollment in this research project?

"Patients aged 18-100 are eligible to participate in this medical trial. An additional 63 studies have been established for minors, while 145 other studies accept applicants above the age of 65." - Anonymous Online Contributor

Unverified Answer

What is the current enrollment limit for participants in this investigation?

"Indeed, the details available on clinicaltrials.gov demonstrate that this medical study is actively recruiting participants. It was initially posted August 23rd 2022 and has since been revised November 10th of the same year. Currently, 92 individuals are needed to participate from a single site." - Anonymous Online Contributor

Unverified Answer

Has the FDA approved a regimen of Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration Tacrolimus?

"As it is only in its second phase of clinical trials, there exists some evidence confirming the safety of Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept and Short-Duration Tacrolimus but no information on efficacy so far. Therefore, we have assigned this drug a rating of 2." - Anonymous Online Contributor

Unverified Answer

Am I eligible to partake in this clinical investigation?

"Admission to this medical trial is available for those aged 18-100 suffering from a specified condition. As of right now, 92 potential participants have been identified." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.