Hematopoietic Recovery
Conditions
Keywords
Hematopoietic recovery, sUCBT
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Anhui Provincial Hospital
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 60 years (inclusive) at screening; gender is not restricted; * Diagnosed with hematological malignancies to receive sUCBT for the first time; * No severe organ failure and no active infections * ECOG performance status of 0-2; * Voluntarily participating in the clinical trial, with full understanding of the trial details and having signed the informed consent form.
Exclusion criteria
* Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas; * Pregnant patients; * Patients and/or authorised family members who refuse to receive Coenzyme I for Injection; * Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety and put the results of the study at undue risk; drug-dependent individuals; patients with uncontrolled psychiatric disorders; and individuals with cognitive impairment; * Participants in other clinical studies affecting hematopoietic recovery within 3 months; * Those who are considered by the investigator to be unsuitable for enrolment (e.g., those who anticipate that the patient will not be able to adhere to the examination and treatment due to financial or other issues).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event(AE) | From the date of initial treatment to 30 days after transplantation | Number of treatment-related adverse events as assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of neutrophil engraftment on day 16 | 16 days post transplantation | Cumulative incidence of neutrophil engraftment on day 16 post transplantation. |
| platelet engraftment time | 180 days post transplantation | The first day of platelet count ≥ 20×10\^9/L for 7 consecutive days without platelet transfusions for 7 consecutive days post transplantation. |
| Cumulative incidence of platelet engraftment on day 60 | 60 days post transplantation | Cumulative incidence of platelet engraftment on day 60 post transplantation. |
| Cumulative incidence of primary graft failure on day 30 | 30 days post transplantation | Cumulative incidence of primary graft failure on day 30 post transplantation. |
| Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100 | 100 days post transplantation | Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100 post transplantation. |
| Neutrophil engraftment time | 42 days post transplantation | The first day of absolute neutrophil count ≥ 0.5×10\^9/L for 3 consecutive days post transplantation. |
| Cumulative incidence of relapse on day 180 | 180 days post transplantation | Cumulative incidence of relapse on day 180 post transplantation. |
| Probability of overall survival | 180 days post transplantation | Probability of overall survival on day 180 post transplantation. |
| Probability of leukemia-free survival | 180 days post transplantation | Probability of leukemia-free survival on day 180 post transplantation. |
| Probability of GVHD-free relapse-free survival | 180 days post transplantation | Probability of GVHD-free relapse-free survival on day 180 post transplantation. |
| Cumulative incidence of transplant-related mortality on day 180 | 180 days post transplantation | Cumulative incidence of transplant-related mortality on day 180 post transplantation. |
Countries
China
Contacts
Primary ContactXiaoyu Zhu, Ph.D
Backup ContactYue Wu, M.D
Outcome results
None listed