Recruiting
Phase 1
Phase 2

Cyclophosphamide, Bortezomib, Abatacept

Sponsor:

Northwell Health

Code:

NCT06681922

Conditions

Graft Vs Host Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cyclophosphamide, Bortezomib, Abatacept

Study Details

Brief summary:

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

Graft Vs Host Disease

Study ID

NCT06681922

Start date

Sep 23, 2024

Status verified date

Dec, 2024

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 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)
  • ALP ≤250 IU/L
  • LVEF >45%
  • Adjusted DLCO >50%
  • Negative HIV serology
  • Negative pregnancy test: Confirmation per negative serum 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 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 consecutive months.
  • 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.
  • Inability to provide informed consent.
  • Patient had myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, 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 is 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

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Cyclophosphamide, Bortezomib, Abatacept

Drug given for prevention of Graft-versus-Host Disease (GvHD) following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Primary outcome measure

  • Determine the MTD of abatacept in combination with PTCy and bortezomib Determine the MTD of abatacept in combination with PTCy and bortezomib Determine the MTD of abatacept in combination with PTCy and bortezomib [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Kelli Cole

5167348900kcole5@northwell.edu

Ahmad Samer Al-Homsi, MD

5165622945asameralhomsi@northwell.edu

Locations

Zuckerberg Cancer Center

Recruiting

Lake Success, New York, United States, 11042

More Information

Sponsor

Northwell Health

Last update posted

Dec 16, 2024

Last verified

Dec, 2024

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 2024-12-16.