RECRUITING

A Study of High Dose Post Transplant Medication for the Prevention of GVHD Following HSCT

Conditions

Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2024-09-23

Study Completion:2027-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06681922

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* • 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 (i.e., post-vasectomy). * Inability to provide informed consent. * Patient had myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure (see Appendix C), 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

Inclusion Criteria

Exclusion 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.

* • 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 (i.e., post-vasectomy).
* Inability to provide informed consent.
* Patient had myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure (see Appendix C), 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

Contacts and Locations

Study Contact

Kelli Cole

CONTACT

5167348900

kcole5@northwell.edu

Study Locations (Sites)

Zuckerberg Cancer Center

Lake Success, New York, 11042

United States

Collaborators and Investigators

Sponsor: Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-23

Study Completion Date2027-10

Study Record Updates

Study Start Date2024-09-23

Study Completion Date2027-10

Terms related to this study

Additional Relevant MeSH Terms

Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy