Timing the donor stem cell infusion to reduce acute graft-versus-host disease after donor blood stem cell transplant

A Multicenter Randomized Controlled Study of the Effect of Stem Cell Infusion Time on the Development of aGVHD in Patients With Nonmalignant Hematologic Diseases After Allogeneic Peripheral Blood Hematopoietic Stem Cell Transplantation

This trial tests whether changing the clock time when donor peripheral blood stem cells are given can lower the risk and severity of acute graft-versus-host disease in people aged 12–60 having their first allogeneic peripheral blood stem cell transplant for nonmalignant blood disorders.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (estimated)
• Ages: 12 Years to 60 Years
• Sex: All
• Sponsor: Anhui Provincial Hospital (Government)
• Locations: 6 sites (Hefei, Anhui and 5 other locations)
• Trial ID: NCT06294691 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, multicenter trial assigns patients to different times of day for donor peripheral blood stem cell infusion and follows them prospectively. The primary outcome is the incidence and severity of acute graft-versus-host disease (aGVHD), with secondary outcomes including other transplant-related complications and long-term survival. The rationale is that human immune function follows daily (circadian) rhythms and prior single-center retrospective data suggested infusion time affects aGVHD risk. The trial is being conducted at major tertiary hospitals in China and enrolls patients undergoing their first allo-PBSCT.

Who should consider this trial

Good fit: Ideal candidates are people aged 12–60 with nonmalignant hematologic conditions scheduled for their first allogeneic peripheral blood stem cell transplant, with ECOG 0–2, no serious organ failure or active infection, and able to give informed consent.

Not a fit: People with severe organ dysfunction, uncontrolled active infections, pregnancy, prior allogeneic transplant, or other exclusion conditions are unlikely to benefit from this timing intervention.

Why it matters

Potential benefit: If successful, simply changing when donor cells are given could reduce how often and how severe aGVHD occurs, improving transplant safety and long-term outcomes.

How similar studies have performed: A prior single-center retrospective cohort found a strong association between infusion time and aGVHD, but prospective randomized evidence is currently lacking internationally.

Eligibility criteria

Inclusion Criteria:

* Definite diagnosis of malignant hematologic disease before transplantation, age 12-60 years old, gender is not limited, race is not limited;
* Patients who are proposed to receive allo-PBSCT 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 patient's condition, if the patient'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;
* Pregnant patients;
* Patients and/or authorized family members who refuse to undergo an open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation;
* Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety and put the results of the study at unnecessary risk; drug-dependent individuals; patients 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 and 5 other locations

• The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) — Hefei, Anhui, China (Recruiting)
• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Rui Jin Hospital Affiliated to Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (Recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Xiaoyu Zhu, ph.D — The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
• Study coordinator: Xiaoyu Zhu, ph.D

Conditions Acute Graft-versus-host Disease; Time of stem cell infusion