Recruiting
Phase 1
Phase 2

PTCy, Bortezomib, Abatacept

Sponsor:

Northwell Health

Code:

NCT05289167

Conditions

Graft-versus-host Disease

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

Interventions

Cyclophosphamide

Abatacept

Bortezomib

Study Details

Brief summary:

This is a phase I-II clinical trial. Adult subjects with hematological malignancies undergoing allogeneic HSCT from an HLA matched sibling or ≥7 out of 8 allele level HLA matched unrelated donor are eligible for the study if they meet the criteria defined in our standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Subjects will receive a standard of care conditioning regimen. Subjects will receive investigational PTCy, investigational bortezomib and investigational abatacept as GvHD prophylaxis.

Conditions

Graft-versus-host Disease

Study ID

NCT05289167

Start date

Mar 13, 2022

Status verified date

May, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥14 years
  • Karnofsky score ≥70%
  • No evidence of progressive bacterial, viral, or fungal infection
  • Creatinine clearance >50 mL/min/1.72m2
  • ALT and AST <3 x the upper limit of normal
  • Total bilirubin <2 x the upper limit of normal (except for Gilbert's syndrome)
  • Alkaline phosphatase ≤250 IU/L
  • Left Ventricular Ejection Fraction (LVEF) >45%
  • Adjusted Carbon Monoxide Diffusing Capacity (DLCO) >50%
  • Negative HIV serology
  • Negative pregnancy test: Confirmation per negative serum β-human chorionic gonadotropin (β-hCG)
  • Willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

  • Pregnant or nursing females or women of reproductive capability who are unwilling to completely abstain from heterosexual sex or practice 2 effective methods of contraception from start of conditioning through 90 days after the last dose of study drug. A woman of reproductive capability is one who has not undergone a hysterectomy (removal of the womb), has not had both ovaries removed, or has not been post-menopausal (stopped menstrual periods) for more than 24 months in a row.
  • Male subjects who refuse to practice effective barrier contraception from the start of conditioning through a minimum of 90 days after the last dose of study drug, or completely abstain from heterosexual intercourse. This must be done even if they are surgically sterilized (i.e., post-vasectomy).
  • Inability to provide informed consent.
  • 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 D), 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.
  • Known allergies to any of the components of the investigational treatment regimen.
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma, an in-situ malignancy, or low-risk prostate cancer after curative therapy.
  • Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.
  • Prisoners
  • Pregnant women

Study Design

Enrollment

74 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with hematological malignancies

Participants undergoing Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) will receive a combination of cyclophosphamide, known commercially as Cytoxan®, abatacept, known as Orecia® and bortezomib commercially known as Velcade®, to reduce the rate of graft-versus-host disease (GvHD). These medications will be given for GvHD prevention during the transplant process.

Interventions

Cyclophosphamide

37.5 mg/kg IV over 1 hour on Day +3 and +4

Abatacept

Dose level 0: 10 mg/kg IV over 30-60 minutes on day +5

Dose level 1: 10mg/kg IV over 30-60 minutes on day +5 and +14

Dose level 2: 10mg/kg IV over 30-60 minutes on day +5, +14, and +28

Bortezomib

1.3 mg/m2 IV 6 hours after graft infusion completion and 72 hours thereafter.

Primary outcome measure

  • Phase I:Incidence Dose limiting toxicity (DLT) [ Time Frame: Day+1 to Day +120 ]
  • Phase II: Grades II-IV Acute GvHD [ Time Frame: Day+1 to Day +120 ]

Central Contacts and Locations

Central contacts

Kelli Cole

516-734-8973kcole5@northwell.edu

Angie Fleury

516-734-8973AFleury2@northwell.edu

Locations

Northwell Health

Recruiting

New Hyde Park, New York, United States, 10016

Contacts

Kelli Cole

516-734-8973kcole5@northwell.edu

Angie Fleury

516-734-8973AFleury2@northwell.edu

Principal Investigator:

A. Samer Al-Homsi, MD, MBA

More Information

Sponsor

Northwell Health

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • GvHD, post transplant cyclophosphamide, abatacept

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-05-29.