Impact of stem cell infusion timing on acute graft-versus-host disease in blood cancer patients

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

This study is testing whether the timing of stem cell infusions can help reduce the risk of acute graft-versus-host disease in blood cancer patients receiving stem cell transplants.

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: NCT06294678 on ClinicalTrials.gov

What this trial studies

This study investigates how the timing of stem cell infusion affects the development of acute graft-versus-host disease (aGVHD) in patients with hematological malignancies undergoing allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT). It aims to randomize patients based on the timing of the infusion and observe its impact on aGVHD incidence, transplant-related complications, and long-term survival. The study is motivated by previous findings suggesting that infusion timing may significantly influence aGVHD outcomes, and it seeks to provide prospective data to support this hypothesis.

Who should consider this trial

Good fit: Ideal candidates include patients aged 12-60 with a confirmed diagnosis of malignant hematologic disease who are undergoing their first allo-PBSCT.

Not a fit: Patients with severe organ dysfunction or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved strategies for preventing aGVHD, enhancing patient outcomes after stem cell transplantation.

How similar studies have performed: While previous studies have suggested a link between infusion timing and aGVHD incidence, this approach is novel in the context of a prospective clinical trial.

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, 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, 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