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

Why it matters

Who can join: the full rules

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 it's running

• 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 University of Science and Technology of China
• 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

  This will try a dental cleaning about 28 days after an allogeneic stem cell transplant to see if it lowers the chance of chronic graft-versus-host disease in adult transplant recipients.

  Recruiting Fred Hutchinson Cancer Center · Seattle, Washington · NCT07535008

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

  This trial will test whether adding jaktinib to standard steroids helps adults with grade II–IV acute graft-versus-host disease after an allogeneic stem cell transplant.

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

• Ruxolitinib treatment for acute graft-versus-host disease

  This study is testing if ruxolitinib can help people with acute graft-versus-host disease who haven't improved with regular steroid treatments.

  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

• Preventing severe acute graft‑versus‑host disease in high‑risk adults with an anti‑CD25 antibody

  This trial will try a recombinant humanized anti‑CD25 antibody to prevent severe aGVHD in adults the daGOAT model flags as intermediate‑to‑high risk after allogeneic stem cell transplant.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT06880419

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.