HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib

Launched by HENRY FORD HEALTH SYSTEM · Feb 20, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new approach for patients with blood cancers who need a stem cell transplant but do not have a fully matched donor. The study is testing a method called haploidentical stem cell transplantation, which allows patients to receive stem cells from a partially matched family member. Researchers want to see how well this method works when combined with two medications, post-transplant cyclophosphamide and bortezomib, which aim to reduce the risk of complications like graft-versus-host disease (GVHD) and help the immune system recover more effectively after the transplant.

To be eligible for this trial, participants must be between 18 and 65 years old, have a related donor who is a partial match, and have a type of blood cancer that requires a transplant. They should also be in good overall health, meaning they can perform daily activities with little difficulty. If someone joins the trial, they can expect close monitoring and support during the transplant process. It's important to note that this study is currently recruiting participants and aims to improve treatment options for those who lack suitable donors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18-65 years old patient lacking a matched related donor or unrelated donor but have a related haploidentical donor (\</= 7/8 allele match at the A, B, C, DR loci with a minimum match of 5/10 is required) is identified
• • Candidate for stem cell transplant in a malignant hematological condition
• • Karnofsky Performance Scale 0-1
• • Available donor able to undergo a Peripheral blood stem cells collection
• • Bilirubin \</= 1.5 mg/dl , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \</= 200 IU/ml for adults.
• • Serum creatinine clearance \>/=60 ml/min (calculated with Cockroft-Gault formula)
• • Diffusing capacity for carbon monoxide (DLCO) \>/= 45% predicted corrected for hemoglobin.
• • Left ventricle ejection fraction \> 40%.
• • Patient or patient's legal representative, parent(s) or guardian should provide written informed consent.
• Exclusion Criteria:
• • Adult who has a suitable related or unrelated donor or cord units available for transplant. Suitable donors include 8/8 (HLA-A,B,C and DR, with all loci high-resolution typing) or 7/8 related or unrelated donor available within 42 days of search initiation
• • HIV positive; active hepatitis B or C
• • Patients with active uncontrolled infections.
• • Liver cirrhosis
• • Uncontrolled central nervous system involvement by tumor cells
• • Positive Beta Human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
• • Inability to comply with medical therapy or follow-up