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Alkylating agents

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

Phase 2

Recruiting

Led By Jaime Suarez Londono

Research Sponsored by NYU Langone Health

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 up to day 730

Awards & highlights

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.

Who is the study for?

Adults with blood cancers needing a stem cell transplant from a relative can join if they're over 18, infection-free, have good kidney/liver/heart function, and are generally fit (Karnofsky score ≥ 70%). Women must not be pregnant and agree to contraception. Men must also use contraception. No recent heart attacks or severe heart disease allowed.Check my eligibility

What is being tested?

This phase II trial tests Cyclophosphamide, Abatacept, and Tacrolimus in preventing Graft-versus-Host Disease after stem cell transplants from half-matched donors. It's an open-label study where all participants receive the same drugs following their transplant.See study design

What are the potential side effects?

Possible side effects include immune system suppression leading to increased infection risk, liver/kidney problems due to drug toxicity, potential for allergic reactions to medication components, and general discomfort like nausea or fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 730

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 730

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Cumulative Incidence of Grades II-IV Acute GvHD

Secondary outcome measures

Cumulative Incidence of Chronic GvHD

GvHD and Relapse-Free Survival (GRFS) Rate

Number of Participants Presenting with Poor Graft Function

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration TacrolimusExperimental Treatment3 Interventions

Participants to receive: Cyclophosphamide 25 mg/kg IV over 1 hour on Day 3 and Day 4 following transplant Abatacept 10 mg/kg IV on Day 5, Day 14, Day 28, and Day 56 following transplant Tacrolimus 0.02 mg/kg IV by continuous infusion, starting on Day 5 following transplant. May switch to oral administration when tolerated, adjusted to maintain a drug level between 5-12ng/mL. Tacrolimus treatment is continued until Day 60 and then tapered over a period of 4 weeks in the absence of GvHD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Abatacept

2005

Completed Phase 4

~112150

Tacrolimus

2011

Completed Phase 4

~4740

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

840,475 Total Patients Enrolled

Jaime Suarez LondonoPrincipal InvestigatorNYU Langone Medical Center

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05621759 — Phase 2

Graft-versus-Host Disease Research Study Groups: Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration Tacrolimus

Graft-versus-Host Disease Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT05621759 — Phase 2

Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05621759 — Phase 2

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GvHD

2022. "Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GvHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05621759.

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