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Alkylating Agent

High-Dose CyBor for Graft-versus-Host Disease Prevention

Phase 2
Waitlist Available
Led By Ahmad Al-Homsi, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 730 post-transplant
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help people with blood cancer who are getting a stem cell transplant.

Who is the study for?
Adults with blood cancers eligible for stem cell transplants from donors can join this trial if their kidneys, heart, liver, and lungs are functioning well. They must not have severe infections or other serious illnesses that could affect participation. Men must agree to use contraception or abstain from sex, and women of childbearing potential must do the same or be unable to become pregnant.Check my eligibility
What is being tested?
The trial is testing a combination of high-dose Cyclophosphamide and Bortezomib (CyBor) as a way to prevent Graft-versus-Host Disease after receiving stem cells from a donor. All participants will receive this treatment following specific chemotherapy and immune suppression therapy.See study design
What are the potential side effects?
Cyclophosphamide may cause nausea, hair loss, mouth sores, and increased risk of infection. Bortezomib can lead to nerve damage resulting in pain or numbness, diarrhea, rash, fatigue, low platelet counts which increases bleeding risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 730 post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 730 post-transplant 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 Who Experience Acute GvHD
Percentage of Participants Who Experience Moderate to Severe Chronic GvHD
Secondary outcome measures
Graft Versus Host Disease Relapse Free Survival (GRFS)
Incidence of Poor Graft Function
Incidence of Primary Graft Failure
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cyclophosphamide and BortezomibExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Bortezomib
2005
Completed Phase 2
~1140

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,698 Total Patients Enrolled
Ahmad Al-Homsi, MDPrincipal InvestigatorNew York Langone Medical Center
1 Previous Clinical Trials
74 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03945591 — Phase 2
Graft-versus-Host Disease Research Study Groups: Cyclophosphamide and Bortezomib
Graft-versus-Host Disease Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03945591 — Phase 2
Cyclophosphamide (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03945591 — Phase 2

Frequently Asked Questions

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

How is Bortezomib usually given to patients?

"Bortezomib is an effective treatment for patients struggling with multiple sclerosis, mixed-cell type lymphoma, and leukemia, myelocytic, acute."

Answered by AI

Are there any life-threatening risks associated with Bortezomib?

"There is some evidence that suggests Bortezomib might be safe based on data from Phase 2 trials. However, there is no clinical data yet supporting its efficacy."

Answered by AI

Is Bortezomib only being tested in this one trial, or have their been other studies with this drug?

"There are currently 959 clinical trials studying the efficacy of Bortezomib. Of these, 185 are in Phase 3. Many of the trials related to this medication are based out of Philadelphia, although there are 34802 total locations running these sorts of tests."

Answered by AI

Are people still signing up to participate in this research project?

"This particular clinical trial is not currently recruiting patients. The study was initially posted on June 20th, 2019 and was last edited on April 15th, 2022. However, if the individual is looking for other studies to participate in, there are 959 studies actively searching for patients with Bortezomib and 172 studies actively searching for participants with Graft vs Host Disease."

Answered by AI

How many people are eligible to participate in this clinical research?

"This study is no longer recruiting participants. The trial was first posted on 6/20/2019 and was most recently updated on 4/15/2022. If you are exploring for other studies, there are currently 172 studies actively recruiting participants with graft vs host disease and 959 studies for Bortezomib actively enrolling patients."

Answered by AI

What is the main goal of this clinical trial?

"The main goal of this trial, which will take place over the course of 45 days, is to study the incidence of Acute GvHD. Additionally, researchers are looking at Treatment Related Mortality (TRM), Relapse Rate (RR), and Poor graft function as secondary outcomes."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
2019. "High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03945591.
~4 spots leftby Apr 2025
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