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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
Must not have
Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Appendix E), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
Donors are excluded in case of donor-specific HLA antibodies or positive cross-match.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 730
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am 18 years old or older.
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I do not have any worsening infections.
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I am able to care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had a heart attack or severe heart issues in the last 6 months.
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I don't have antibodies against the donor's tissues.
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I am not pregnant or nursing and will use birth control if of childbearing age.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Grade II-IV Acute GvHD by Day +120
Secondary study objectives
Cumulative Incidence of Chronic GvHD
Cumulative Incidence of Poor Graft Function
Cumulative Incidence of Primary Graft Failure
+5 more

Side effects data

From 2024 Phase 1 & 2 trial • 46 Patients • NCT04503616
15%
CMV reactivation
13%
Mucositis
13%
Febrile neutropenia
11%
Acute kidney injury
9%
Fever
9%
Headache
9%
Bacteremia
7%
Hypoxia
7%
Cytomegalovirus (CMV) reactivation
7%
Blood bilirubin increased
4%
Dysuria
4%
Hematuria
4%
Dyspnea
4%
Papulopustular rash
4%
Epitaxis
4%
Sinusoidal obstruction syndrome
4%
Cough
4%
Anorexia
4%
Diarrhea
2%
Flu like symptoms
2%
Urinary tract infection
2%
Colitis
2%
Lethargy
2%
Conjunctival hemorrhage
2%
Fatigue
2%
Confusion
2%
Stridor
2%
Tremor
2%
Abdominal pain
2%
Facial nerve disorder
2%
Infusion related reaction
2%
Hypertension
2%
Toxoplasmosis infection
2%
Thrombotic microangiopathy
2%
EBV reactivation
2%
Pneumonia
2%
Hematochezia with colostomy
2%
Pericardial tamponade
2%
Wheezing
2%
Pericardial effusion
2%
Graft-versus-host disease (GvHD)
2%
Delirium
2%
Meningitis
2%
Nausea
2%
Cytokine release syndrome
2%
Creatinine increase
2%
Respiratory failure
2%
Generalized muscle weakness
2%
Multiorgan failture
2%
Epstein-Barr Virus (EBV) reactivation
2%
Rectal ulcer
2%
Pulmonary airspace opacities
2%
Pulmonary infiltrates
2%
Hyperglycemia
2%
Hyponatremia
2%
Viremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
HSCT Patients

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention
2020
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,408 Previous Clinical Trials
855,739 Total Patients Enrolled
1 Trials studying GVHD
23 Patients Enrolled for GVHD
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
GVHD Research Study Groups: HSCT Patients
GVHD 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
~9 spots leftby Nov 2025
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