The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China, 310003
Location status: Recruiting
NCT Number: NCT06809699
This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use human leukocyte antigen (HLA) mismatched donors. Ultimately, a HLA mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of these patients and truly enter the era of "everyone has a donor".
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Phase 1
Hangzhou, China, 310003
Location status: Recruiting
This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use human leukocyte antigen (HLA) mismatched donors. Ultimately, a HLA mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of these patients and truly enter the era of "everyone has a donor".
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For myeloablative conditioning: Busulfan (Bu,3.2 mg/kg/d IV -8d ~-6d) For reduced intensity conditioning: (Bu,3.2 mg/kg/d IV -7d~-5d)
Cyclophosphamide is only used in myeloablative conditioning (Cy,1.8g/m2, -5d, -4d)
For myeloablative conditioning: Fludarabine (Flu,30 mg/m2/d IV -6d ~ -2d) For reduced intensity conditioning: Fludarabine(Flu,30mg/m2 /d IV -10d~-5d)
For both myeloablative and reduced intensity conditioning: Semustine (MECCNU,250 mg/m2 orally-3d).
Time frame: 1-year
Overall survival after allogeneic cell transplantation refers to the length of time a patient remains alive from the date of transplantation, regardless of disease status or complications.
Time frame: 28 days
The neutrophil engraftment rate is assessed, and neutrophil engraftment is defined as achievement of an absolute neutrophil count (ANC) of ≥ 0.5 × 10⁹/L for three consecutive days
Time frame: 28 days
Platelet engraftment rate is assessed, and platelet engraftment is defined as achievement of a platelet count of ≥ 20 × 10⁹/L (or ≥ 50 × 10⁹/L in some definitions) without transfusion support for at least seven consecutive days.
Time frame: 1-year
Cumulative incidence of relapse
Time frame: 1-year
Progression-free survival after allogeneic cell transplantation refers to the length of time during which a patient remains alive without any signs of disease relapse or progression.
Time frame: 1-year
Progression-free survival after allogeneic cell transplantation refers to the length of time during which a patient remains alive without any signs of disease relapse or progression.
Time frame: 1-year
GRFS (Graft-versus-host disease-free, relapse-free survival) after allogeneic cell transplantation is the length of time a patient remains alive without experiencing significant graft-versus-host disease, disease relapse, or death.
Interested in participating?
Request InfoHe Huang
Other
A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Related Allogeneic Hematopoietic Stem Cell Transplantation
Acronym: HIGHT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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