The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, 310003, China
Location status: Recruiting
Location contact
He Huang
PRINCIPAL_INVESTIGATOR
Yishan Ye
CONTACT
Yishan Ye, MD., PhD
SUB_INVESTIGATOR
NCT Number: NCT06809712
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 highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Phase 1
Hangzhou, 310003, China
Location status: Recruiting
He Huang
PRINCIPAL_INVESTIGATOR
Yishan Ye
CONTACT
Yishan Ye, MD., PhD
SUB_INVESTIGATOR
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 highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Myeloablative conditioning: Busulfan (Bu,3.2 mg/kg/d IV -8d ~-6d); Reduced intensity conditioning: Busulfan (Bu,3.2 mg/kg/d IV -7d~-5d);
Myeloablative conditioning: Cyclophosphamide (Cy,1.8g/m2, -5d, -4d) Cyclophosphamide is not used for reduced intensity conditioning
Myeloablative conditioning: Fludarabine (Flu,30 mg/m2/d IV -6d ~ -2d); 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 (OS) after allogeneic hematopoietic cell transplantation is defined as the proportion of patients who are alive at a specified time point following the transplantation, regardless of disease status or cause of death.
Time frame: 28-days
The 28-day neutrophil engraftment rate is assessed, with neutrophil engraftment defined as achievement of an absolute neutrophil count (ANC) of ≥ 0.5 × 10⁹/L for three consecutive days.
Time frame: 28-days
The 28-day platelet engraftment rate is assessed, with platelet engraftment defined as achievement of a platelet count of ≥ 20 × 10⁹/L without transfusion support for at least seven consecutive days.
Time frame: 180 days and 2 year
Cumulative incidence of aGvHD and cGvHD in different target organs and overall population.
Time frame: 1-year
Cumulative incidence of disease relapse after transplantation.
Time frame: 1-year
Progression-free survival (PFS) after allogeneic hematopoietic cell transplantation is defined as the length of time a patient survives without evidence of disease progression or relapse following the transplantation.
Time frame: 1-year
Graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS) after allogeneic hematopoietic cell transplantation is defined as the time a patient survives without experiencing grade III-IV acute GVHD, severe chronic GVHD, relapse, or death.
Contact information is provided by the study sponsor or research team.
He Huang
Other
A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation
Acronym: MIGHT
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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