Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06681922

A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Abatacept for the Prevention of Graft-Versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Led by Northwell Health · Updated on 2024-12-16

10

Participants Needed

1

Research Sites

157 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study will be conducted in two phases. The phase I portion will employ a 3+3 dose-escalation design to define the maximum tolerated dose (MTD) of abatacept added to PTCy and bortezomib following HSCT. The phase II portion will consist of two single-arm, open-label, optimal 2-stage Simon design studies conducted in two separate strata for HLA-matched and HLA-mismatched donor transplants.

CONDITIONS

Official Title

A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Abatacept for the Prevention of Graft-Versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 18 years
  • Karnofsky score 65 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)
  • ALP 65 250 IU/L
  • Left ventricular ejection fraction >45%
  • Adjusted DLCO >50%
  • Negative HIV test
  • Negative pregnancy test confirmed by serum b2-hCG
  • Willing to comply with all study procedures and be available for the duration of the study.
Not Eligible

You will not qualify if you...

  • Pregnant or nursing females or women of reproductive capability unwilling to abstain from heterosexual sex or use effective contraception from start of conditioning through 90 days after last study drug dose
  • Male subjects refusing to use effective barrier contraception or abstain from heterosexual intercourse during the same period
  • Unable to provide informed consent
  • Recent myocardial infarction within 6 months or severe heart conditions including NYHA Class III or IV heart failure, uncontrolled angina, severe ventricular arrhythmias, or acute ischemia
  • Known allergies to any components of the treatment regimen
  • Serious medical or psychiatric illness interfering with study participation
  • Diagnosed or treated for another malignancy within 3 years, except certain skin cancers or low-risk prostate cancer after curative therapy
  • Participation in other investigational drug trials within 14 days before and during this trial
  • Prisoners
  • Pregnant women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zuckerberg Cancer Center

Lake Success, New York, United States, 11042

Actively Recruiting

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Research Team

K

Kelli Cole

CONTACT

A

Ahmad Samer Al-Homsi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

0

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