To assess the safety and efficacy of coenzyme I for injection in promoting hematopoietic recovery after single-unit unrelated cord blood transplantation in hematological malignancies.
A single-center, open-label, dose-escalation study to assess the safety and efficacy of coenzyme I for injection in promoting hematopoietic recovery after single-unit unrelated cord blood transplantation in hematological malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Subjects received 21 consecutive days of intravenous infusion of Coenzyme I for injection, starting from the day of transplantation , and then continuously applied intravenously until 20 days post transplantation, with three dose groups: subjects #1-3 received one intravenous infusion per day containing 10 mg of Coenzyme I for injection, subjects #4-6 received one intravenous infusion per day containing 20 mg of Coenzyme I for injection, and subjects #7-12 received one intravenous infusion per day containing 50 mg of Coenzyme I for injection. Subjects in either dose group experienced a treatment-related Grade 3 or higher adverse reaction, the previous dose group was the maximum tolerated dose.
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
RECRUITINGAdverse Event(AE)
Number of treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From the date of initial treatment to 30 days after transplantation
Neutrophil engraftment time
The first day of absolute neutrophil count ≥ 0.5×10\^9/L for 3 consecutive days post transplantation.
Time frame: 42 days post transplantation
Cumulative incidence of neutrophil engraftment on day 16
Cumulative incidence of neutrophil engraftment on day 16 post transplantation.
Time frame: 16 days post transplantation
platelet engraftment time
The first day of platelet count ≥ 20×10\^9/L for 7 consecutive days without platelet transfusions for 7 consecutive days post transplantation.
Time frame: 180 days post transplantation
Cumulative incidence of platelet engraftment on day 60
Cumulative incidence of platelet engraftment on day 60 post transplantation.
Time frame: 60 days post transplantation
Cumulative incidence of primary graft failure on day 30
Cumulative incidence of primary graft failure on day 30 post transplantation.
Time frame: 30 days post transplantation
Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100
Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100 post transplantation.
Time frame: 100 days post transplantation
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Cumulative incidence of transplant-related mortality on day 180
Cumulative incidence of transplant-related mortality on day 180 post transplantation.
Time frame: 180 days post transplantation
Cumulative incidence of relapse on day 180
Cumulative incidence of relapse on day 180 post transplantation.
Time frame: 180 days post transplantation
Probability of overall survival
Probability of overall survival on day 180 post transplantation.
Time frame: 180 days post transplantation
Probability of leukemia-free survival
Probability of leukemia-free survival on day 180 post transplantation.
Time frame: 180 days post transplantation
Probability of GVHD-free relapse-free survival
Probability of GVHD-free relapse-free survival on day 180 post transplantation.
Time frame: 180 days post transplantation