Timing of umbilical cord blood infusion and risk of acute graft-versus-host disease after transplant

Prospective Randomized Controlled Phase III Clinical Study on the Impact of Stem Cell Infusion Timing on the Incidence of Acute Graft-versus-host Disease in Patients With Hematologic Malignancies Following Single-unit Umbilical Cord Blood Transplantation

This trial will test whether giving a single-unit unrelated umbilical cord blood transplant at different times of day changes the chance of acute graft-versus-host disease in people with malignant blood disorders who are in remission.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sex: All
• Sponsor: Anhui Provincial Hospital (Government)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT07047456 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized Phase 3 trial that assigns patients undergoing single-unit unrelated cord blood transplantation to different infusion times to compare outcomes. The study is based on circadian biology findings suggesting recipient physiology varies over 24 hours and may influence graft immune reactions. Primary outcomes include incidence and severity of acute graft-versus-host disease, with secondary outcomes covering other transplant-related complications and long-term survival. All participants will have achieved remission with negative MRD before transplant and will be treated and followed at the coordinating center.

Who should consider this trial

Good fit: Ideal candidates are people with malignant hematologic diseases in complete remission with negative MRD who are planned for a first single-unit unrelated cord blood transplant, have ECOG 0–2, no serious organ failure or active infection, and can give informed consent.

Not a fit: Patients who are not receiving single-unit umbilical cord blood transplants, have active infections, severe organ failure, prior allogeneic transplants, or who are MRD-positive are unlikely to benefit from this timing intervention.

Why it matters

Potential benefit: If successful, selecting an optimal infusion time could reduce the incidence and severity of aGVHD, lower transplant-related mortality, and improve long-term survival for cord blood transplant recipients.

How similar studies have performed: Preliminary and retrospective data and pilot experiments suggest infusion timing can influence aGVHD, but randomized prospective trials addressing infusion time after allo-HSCT are novel.

Eligibility criteria

Inclusion Criteria:

* Definite diagnosis of malignant hematologic disease before transplantation, age, gender and race are not limited;
* Participants were required to have achieved complete remission with negative minimal residual disease (MRD) prior to transplantation;
* Participants who are proposed to receive sUCBT for the first time;
* Eastern Cooperative Oncology Group (ECOG) score 0-2;
* No serious organ failure and active infection;
* Voluntary open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation;
* Each subject must sign an informed consent form (ICF) indicating that he/ she understands the purpose and procedures of the study and is willing to participate in the study; in view of the subject's condition, if the participant's own signature is not conducive to the treatment of his/her condition, the ICF will be signed by the legal representative.

Exclusion Criteria:

* Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas;
* Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise participant safety and put the results of the study at unnecessary risk; drug-dependent individuals; participants with uncontrolled psychiatric disorders; and individuals with cognitive dysfunction;
* Participants in other clinical studies that may affect aGVHD within 3 months;
* Those whom the investigator considers unsuitable for enrollment (e.g., those who anticipate that patients will not be able to adhere to the examination and treatment due to financial and other issues).

Where this trial is running

Hefei, Anhui

• The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital — Hefei, Anhui, China (Recruiting)

Study contacts

• Principal investigator: Xiaoyu Zhu, Ph.D — The First Affiliated Hospital of USTC
• Study coordinator: Xiaoyu Zhu, Ph.D

Conditions Acute Graft Versus Host Disease; Time of umbilical cord blood infusion