Study on Ruxolitinib for Preventing Graft-Versus-Host Disease in Patients Receiving Stem Cell Transplants for Blood Cancers
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT07359859
This clinical trial is comparing two different methods to prevent graft-versus-host disease (GVHD) in patients with blood cancers who are undergoing stem cell transplants. The study aims to find out which method is more effective at preventing chronic GVHD up to one year after the transplant.
Patient Parameters
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Program Overview
The purpose of this study is to compare two different approaches to prevent graft-versus-host disease (GVHD) in patients with blood cancers who are receiving a stem cell transplant. Researchers want to determine which method is more effective at preventing chronic GVHD for up to one year after the transplant.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 years or older.
- Diagnosed with a blood cancer that is in remission, meaning the cancer is under control with less than 5% cancer cells and no signs of disease outside the bone marrow.
- Patients with certain types of blood cancer, like lymphoma, must have shown a complete or partial response to treatment.
- Must have a related or unrelated donor who is a 7-8/8 HLA match or a related haploidentical match.
- Must have a Karnofsky performance score of 70% or higher, indicating they are able to care for themselves and carry out normal activities.
- Women of childbearing age (under 50 years old) must have a negative pregnancy test and agree to use two forms of birth control during the study and for three months after the last dose of the study drug.
- Men who are sexually active with women of childbearing potential must agree to use two forms of birth control and not donate sperm during the study and for three months after the last dose of the study drug.
Exclusion Criteria
- Cannot have received a specific type of stem cell graft that is CD34+ selected or engineered.
- Cannot have been treated with certain medications that deplete T cells, like anti-thymocyte globulin.
- Cannot have severe kidney problems, such as a serum creatinine level over 2 mg/dL or require dialysis.
- Cannot have used any investigational drugs within 14 days before the stem cell transplant.
- Cannot have uncontrolled heart problems, such as high blood pressure, irregular heartbeats, heart failure, chest pain, or a heart attack in the past six months.
- Cannot have uncontrolled mental health issues.
- Women who are pregnant or breastfeeding cannot participate.
- Cannot have an allergy or sensitivity to the study drug, ruxolitinib.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited Protocol Activites) | 11553 | Rockville Centre | New York |
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