A Phase 1 interventional study of Coenzyme I for Injection in Hematopoietic Recovery, sponsored by Anhui Provincial Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Anhui Provincial Hospital · Phase 1, Interventional, and Treatment
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.
Anhui Provincial Hospital is the lead sponsor of 129 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects received 21 consecutive days of intravenous infusion of Coenzyme I for injection with three dose groups.
Drug: Coenzyme I for Injection
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.
Adverse 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
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
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Anhui Provincial Hospital