Study on HLA-Haploidentical Stem Cell Transplant with Post-Transplant Cyclophosphamide and Bortezomib
Sponsor: Henry Ford Health System
ClinicalTrials ID:NCT03850366
This clinical trial is exploring a new approach to stem cell transplantation for patients with blood cancers who do not have a fully matched donor. The study aims to improve the success of transplants using a combination of medications to prevent complications and enhance recovery.
Patient Parameters
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Program Overview
This study is testing a new method for stem cell transplants in patients with blood cancers who need a donor but don't have a fully matched one. The approach uses a partially matched family donor and includes medications like cyclophosphamide and bortezomib to prevent complications such as graft versus host disease (GVHD) and to help the immune system recover. The goal is to see how well this method works in helping the new stem cells grow and function in the patient's body.
Eligibility Criteria
Inclusion Criteria
- Aged 18 to 65 years old.
- Need a stem cell transplant for a blood cancer but don't have a fully matched donor.
- Have a partially matched family donor (at least 5 out of 10 genetic markers match).
- In good general health with a performance status score of 0 or 1.
- Have a donor who can provide stem cells from their blood.
- Liver function tests within specified limits.
- Kidney function with creatinine clearance of at least 60 ml/min.
- Lung function with a DLCO of at least 45%.
- Heart function with an ejection fraction over 40%.
- Able to provide informed consent or have a legal representative do so.
Exclusion Criteria
- Have a fully matched donor available.
- HIV positive or have active hepatitis B or C.
- Have uncontrolled infections.
- Have liver cirrhosis.
- Have uncontrolled cancer in the central nervous system.
- Positive pregnancy test in women who can have children.
- Unable to follow medical instructions or attend follow-up appointments.
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