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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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 China University of Science and Technology (Anhui Provincial)
• Study coordinator: Xiaoyu Zhu, ph.D
• Email: xiaoyuz@ustc.edu.cn
• Phone: 15255456091

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Moxibustion with second-line treatment for steroid-refractory acute graft-versus-host disease after transplant

  This study will test whether adding moxibustion to standard second-line drug therapy helps people aged 14–65 with steroid-refractory gastrointestinal acute GVHD after an allogeneic stem cell transplant.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07572669

• Post-transplant dental cleaning to prevent chronic graft-versus-host disease

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• First-line jaktinib plus corticosteroids for acute graft-versus-host disease

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  Recruiting Phase 1/2 First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT07285889

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

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• Ruxolitinib treatment for acute graft-versus-host disease

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  Recruiting at 10 sites Phase 2 Icahn School of Medicine at Mount Sinai · Duarte, California and 13 other locations · NCT06936566

• Using human chorionic gonadotropin to treat acute graft versus host disease

  This study is testing if adding a hormone called hCG to standard steroid treatment can help people with acute graft versus host disease feel better after their stem cell transplant.

  Recruiting Phase 2 Hospital Universitario Dr. Jose E. Gonzalez · Monterrey, Nuevo León · NCT06904599

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.