Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation

Launched by UNIVERSITY OF NEBRASKA · Jan 22, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to improve the health and quality of life of patients who have received a stem cell transplant for blood cancers or serious blood disorders. Specifically, it will compare two different doses of a medication called cyclophosphamide, which is given after the transplant to help prevent a condition known as graft-versus-host disease (GVHD). GVHD can happen when the donated cells attack the recipient's body. The trial aims to see if a lower dose of this medication, combined with two other drugs, works just as well as the standard dose.

To participate in this trial, you need to be at least 60 years old and have a diagnosis that requires a stem cell transplant. You must also have a matched donor for the transplant and be in good overall health, as indicated by a performance status score of 70% or higher. However, those with certain medical conditions or who have had previous stem cell transplants may not be eligible. If you join the trial, you will be closely monitored for your health and the effects of the treatment to ensure your safety and well-being.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Adults aged 60 years or older
• • Diagnosis of a hematological malignancy or other serious hematological disorder that requires an allogeneic hematopoietic cell transplantation
• • Planned to receive any reduced-intensity conditioning regimen (any graft source is acceptable) and availability of human leukocyte antigen (HLA)-matched donor at HLA loci A, B, C, and HLA-DR beta chain antigen (DRB1)
• • Karnofsky Performance Status (KPS) of 70% or higher.
• Exclusion criteria:
• • Previous history of one or more prior allogeneic stem cell transplants (i.e., second or third allogeneic transplant)
• • Planned use of high doses of cyclophosphamide (e.g., a total cyclophosphamide dose of approximately 50 mg/kg or more) as part of the conditioning regimen prior to allogeneic stem cell transplant. A lower dose of cyclophosphamide (e.g., fludarabine, cyclophosphamide, and low-dose total body irradiation regimen that uses 2 doses of cyclophosphamide at 14.5 mg/kg) is acceptable.
• • Known diagnosis of liver cirrhosis or other advanced liver disease that may impact cyclophosphamide metabolism.
• • Diagnosis of myelofibrosis
• • Creatinine clearance less than 40 mL/min/1.73 m², which may increase the risk of hemorrhagic cystitis with post-transplant cyclophosphamide (PTCy)
• • Systolic cardiac dysfunction with an ejection fraction of less than 45%.
• • Use of a haploidentical or mismatched donor.
• • Any other condition judged by the physician to increase the risk of toxicities associated with PTCy.