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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
RECRUITING
Hefei
Rui Jin Hospital Affiliated to Shanghai Jiao Tong University
RECRUITING
Shanghai
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Xiaoyu Zhu, ph.D
xiaoyuz@ustc.edu.cn
15255456091
Backup
Yue Wu, M.D
wuyue20160701@163.com
13805601119
Time Frame
Start Date: 2024-03-15
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 198
Treatments
Active_comparator: the early infused group
infused stem cell within 11:30 am and 12:30 am
Sham_comparator: the late infused group
infused stem cell within 5:30 pm and 6:30 pm
Sponsors
Leads: Anhui Provincial Hospital

This content was sourced from clinicaltrials.gov