Cyclophosphamide Abatacept and Tacrolimus for GvHD Prevention

  • STATUS
    Recruiting
  • End date
    Aug 1, 2025
  • participants needed
    46
  • sponsor
    NYU Langone Health
Updated on 11 July 2021
cancer
hematologic malignancy
tacrolimus
cyclophosphamide
carbon monoxide
ejection fraction
fungal infection
myeloablative conditioning
transplant conditioning
abatacept
carbon monoxide diffusing capacity

Summary

This is a single arm, open label, optimal 2-stage Simon design phase Ib-II clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from first- or second-degree haploidentical donor are eligible for the study if they meet the standard criteria defined in our institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive non-myeloablative, reduced-intensity or myeloablative conditioning regimen followed by peripheral blood hematopoietic stem cells. Patients will receive cyclophosphamide, abatacept, and short-duration tacrolimus for GvHD prophylaxis.

Details
Condition Graft-Versus-Host Disease, Graft-Versus-Host Disease (GVHD), graft versus host disease, graft-versus-host-disease
Treatment Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention
Clinical Study IdentifierNCT04503616
SponsorNYU Langone Health
Last Modified on11 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years
Karnofsky score 70%
No evidence of progressive bacterial, viral, or fungal infection
Creatinine clearance > 50 mL/min/1.72m2
Total bilirubin, ALT and AST < 2 x the upper limit of normal (except for diagnosed Gilbert's syndrome)
Alkaline phosphatase 250 IU/L
Left Ventricular Ejection Fraction (LVEF) > 45%
Adjusted Carbon Monoxide Diffusing Capacity (DLCO) > 60%
Negative HIV serology
Negative pregnancy test: confirmation per negative serum -human chorionic gonadotropin (-hCG) for women of childbearing age and potential

Exclusion Criteria

Donors are excluded in case of donor-specific HLA antibodies or positive cross-match
Pregnant or nursing females or women of child bearing age or potential, who are unwilling to completely abstain from heterosexual sex or practice 2 effective methods of contraception from the first dose of conditioning regimen through day +180. 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 during the entire study treatment period and 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 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
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
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
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