NCT06799195 Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation
| NCT ID | NCT06799195 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Nebraska |
| Condition | Hematological Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2025-06-23 |
| Primary Completion | 2031-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 126 participants in total. It began in 2025-06-23 with a primary completion date of 2031-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will compare post-transplant health-related quality of life following the use of standard versus attenuated dose of post-transplant cyclophosphamide in addition to two-drug graft-versus-host disease (GVHD) prophylaxis among recipients of allogeneic hematopoietic stem cell transplant.
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.
Contact & Investigator
Moataz Ellithi, MBChB
PRINCIPAL INVESTIGATOR
University of Nebraska
Frequently Asked Questions
Who can join the NCT06799195 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Hematological Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06799195 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06799195 currently recruiting?
Yes, NCT06799195 is actively recruiting participants. Contact the research team at taylora.johnson@unmc.edu for enrollment information.
Where is the NCT06799195 trial being conducted?
This trial is being conducted at Omaha, United States.
Who is sponsoring the NCT06799195 clinical trial?
NCT06799195 is sponsored by University of Nebraska. The principal investigator is Moataz Ellithi, MBChB at University of Nebraska. The trial plans to enroll 126 participants.