Poor Graft Function
Conditions
Keywords
Secondary poor graft function, Umbilical cord blood mononuclear cells
Brief summary
This study is conducted in a prospective, single-center clinical design and is divided into two stages: dose escalation and dose extension. Patients meeting the diagnostic criteria of secondary poor graft function are selected as the study objects. The safety data of umbilical cord blood mononuclear cells in the treatment of secondary poor graft function are obtained through dose escalation stage, and then one dose is selected for dose extension stage to explore the efficacy of umbilical cord blood mononuclear cells in treating secondary poor graft function.
Interventions
BIOLOGICALDose escalation
Three dose groups are preset. The doses are 2.0×10\^6/kg/time, 3.5×10\^6/kg/time and 5.0×10\^6/kg/ time respectively, in accordance with the 3+3 dose escalation principle, and proceed in turn. Each subject receives conventional treatment plus umbilical cord blood mononuclear cells therapy, with 4 consecutive intravenous infusions of umbilical cord blood mononuclear cells at 1 week intervals.
BIOLOGICALDose extension
According to the safety data of dose escalation stage, one dose group is selected for extension. Each subject receives conventional treatment plus umbilical cord blood mononuclear cells therapy, with 4 consecutive intravenous infusions of umbilical cord blood mononuclear cells at 1 week intervals.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age≥18 years old; gender is not limited. 2. Meet the diagnostic criteria for secondary poor graft function: After 28 days of transplantation, patients who had achieved hematopoietic reestablishment (ANC ≥ 0.5×10\^9/L for 3 consecutive days without G-CSF application, PLT ≥ 20×10\^9/L for 7 consecutive days without platelet infusion, Hb ≥ 80g/L for 2 consecutive weeks without red blood cell infusion) again developed two or three line cytopenia lasting more than 2 weeks. Bone marrow examination revealed low myelodysplasia, remission of primary disease, complete donor chimeric cells, and no severe graft-versus-host disease (GVHD) or disease recurrence. 3. Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2 points. 4. Subjects sign informed consent.
Exclusion criteria
1. Serious infection not controlled. 2. Active bleeding. 3. Patients with cardiac insufficiency (ejection fraction\<50%), or suffering from serious heart disease, including myocardial infarction, cardiac insufficiency, etc. 4. Patients with hepatic and renal insufficiency (total bilirubin\>35µmol/L, ALT and AST\>2 times of the upper limit of normal; serum creatinine\>130µmol/L). 5. Pregnant or lactating women. 6. Concurrent malignant tumors of other organs. 7. Failure to understand or follow the research protocol. 8. Patients participating in other clinical investigations. 9. Other conditions that the investigators consider inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment | From date of the last infusion of umbilical cord blood mononuclear cells until the date of end of follow-up, assessed up to 24 months | Incidence of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The recovery time of platelet | Two months after the last infusion of umbilical cord blood mononuclear cells | The first day of 3 consecutive days with PLT ≥ 20×10\^9/L without platelet transfusion |
| The recovery time of neutrophil | Two months after the last infusion of umbilical cord blood mononuclear cells | The first day of 3 consecutive days with ANC ≥ 0.5×10\^9/L without G-CSF application |
Countries
China
Contacts
Primary Contacterlie EL Jiang
Outcome results
None listed