← Back to Search

Immunomodulator

Cyclophosphamide + Abatacept + Tacrolimus for Graft-versus-Host Disease

Phase 1 & 2

Waitlist Available

Led By Maher Abdul Hay, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

No evidence of progressive bacterial, viral, or fungal infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 730

Awards & highlights

Study Summary

This trial is for adult patients with blood cancer who are undergoing a stem cell transplant from a donor who is a first- or second-degree relative. The patients will receive a reduced-intensity or myeloablative conditioning regimen, followed by peripheral blood hematopoietic stem cells. They will also receive cyclophosphamide, abatacept, and short-duration tacrolimus for GvHD prophylaxis.

Who is the study for?

Adults with blood cancers needing a stem cell transplant from a relative can join this trial if they're over 18, have good organ function, no severe infections or heart issues, and aren't pregnant. They must use effective birth control and not be in prison or on other trials.Check my eligibility

What is being tested?

The study tests Cyclophosphamide, Abatacept, and Tacrolimus as prevention for Graft-versus-Host Disease after non-myeloablative or myeloablative conditioning and stem cell transplant. It's an early-phase trial where everyone gets the same treatment.See study design

What are the potential side effects?

Possible side effects include immune system suppression leading to increased infection risk, liver problems, nausea, mouth sores from Cyclophosphamide; high blood pressure and kidney issues from Tacrolimus; and possible infusion reactions from Abatacept.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

I do not have any worsening infections.

Select...

I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 730

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 730

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 730 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percentage of Participants With Grade II-IV Acute GvHD by Day +120

Secondary outcome measures

Cumulative Incidence of Chronic GvHD

Cumulative Incidence of Poor Graft Function

Cumulative Incidence of Primary Graft Failure

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: HSCT PatientsExperimental Treatment1 Intervention

Adult patients with hematological malignancies undergoing HLA-haploidentical HSCT from first-or second-degree family donors.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,370 Previous Clinical Trials

840,758 Total Patients Enrolled

Maher Abdul Hay, MDPrincipal InvestigatorNYU Langone Health

1 Previous Clinical Trials

74 Total Patients Enrolled

Samer Al-Homsi, MDPrincipal InvestigatorNYU Langone Health

1 Previous Clinical Trials

6 Total Patients Enrolled

Media Library

Abatacept (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT04503616 — Phase 1 & 2

Graft-versus-Host Disease Research Study Groups: HSCT Patients

Graft-versus-Host Disease Clinical Trial 2023: Abatacept Highlights & Side Effects. Trial Name: NCT04503616 — Phase 1 & 2

Abatacept (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04503616 — Phase 1 & 2

Frequently Asked Questions

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

How many people have enrolled in this trial thus far?

"At present, this trial is not enlisting participants. It was first announced on the 21st of July 2020 and last updated on the 5th August 2022. However, there are 169 trials for graft vs host disease and 943 studies for Cyclophosphamide, Abatacept, and Tacrolimus as a preventative measure against GvHD presently recruiting patients."

Answered by AI

Under what conditions is the combination of Cyclophosphamide, Abatacept, and Tacrolimus typically prescribed for GvHD Prevention?

"Cyclophosphamide, Abatacept and Tacrolimus for GvHD Prevention is commonly prescribed to treat dermatitis atopic. Additionally, this drug has been found effective in managing various other ails such as multiple sclerosis, acute leukemia myelocytic transplant rejection or kidney transplants."

Answered by AI

Are there vacancies in the current clinical trial for participants?

"Unfortunately, no new patients are being sought at this time for the trial earlier posted in July 2020 and edited afterwards in August 2022. If you're seeking out other studies instead, 169 trials involving graft vs host disease have open enrollment periods as well as 943 clinical trials examining the effectiveness of Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention currently recruiting participants."

Answered by AI

Have prior studies indicated the efficacy of a combination therapy involving Cyclophosphamide, Abatacept and Tacrolimus in preventing GvHD?

"Presently, there are 943 live studies involving Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention. Of those trials 177 have reached Phase 3 status. Although the majority of these investigations into this treatment take place in Philadelphia, Pennsylvania; across 29140 locations globally research is being conducted on this therapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention

2020. "Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04503616.

All > Gvhd