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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coenzyme I for Injection | Experimental | Subjects received 21 consecutive days of intravenous infusion of Coenzyme I for injection with three dose groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coenzyme I for Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event(AE) | Number of treatment-related adverse events as assessed by CTCAE v5.0 | From the date of initial treatment to 30 days after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Neutrophil engraftment time | The first day of absolute neutrophil count ≥ 0.5×10^9/L for 3 consecutive days post transplantation. | 42 days post transplantation |
| Cumulative incidence of neutrophil engraftment on day 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyu Zhu, Ph.D | Contact | 15255456091 | xiaoyuz@ustc.edu.cn | |
| Yue Wu, M.D | Contact | 13805601119 | 287109658@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoyu Zhu, Ph.D | The First Affiliated Hospital of University of Science and Technology of China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) | Recruiting | Hefei | Anhui | 230036 | China |
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| ID | Term |
|---|---|
| D009243 | NAD |
| D007267 | Injections |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
Cumulative incidence of neutrophil engraftment on day 16 post transplantation.
| 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. | 180 days post transplantation |
| Cumulative incidence of platelet engraftment on day 60 | Cumulative incidence of platelet engraftment on day 60 post transplantation. | 60 days post transplantation |
| Cumulative incidence of primary graft failure on day 30 | Cumulative incidence of primary graft failure on day 30 post transplantation. | 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. | 100 days post transplantation |
| Cumulative incidence of transplant-related mortality on day 180 | Cumulative incidence of transplant-related mortality on day 180 post transplantation. | 180 days post transplantation |
| Cumulative incidence of relapse on day 180 | Cumulative incidence of relapse on day 180 post transplantation. | 180 days post transplantation |
| Probability of overall survival | Probability of overall survival on day 180 post transplantation. | 180 days post transplantation |
| Probability of leukemia-free survival | Probability of leukemia-free survival on day 180 post transplantation. | 180 days post transplantation |
| Probability of GVHD-free relapse-free survival | Probability of GVHD-free relapse-free survival on day 180 post transplantation. | 180 days post transplantation |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |