The Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery of Patients After sUCBT
NCT ID: NCT06558253
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2024-11-29
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Coenzyme I for Injection
Subjects received 21 consecutive days of intravenous infusion of Coenzyme I for injection with three dose groups.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
60 Years
ALL
No
Sponsors
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Anhui Provincial Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Xiaoyu Zhu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of University of Science and Technology of China
Locations
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The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
Countries
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Central Contacts
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Facility Contacts
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Xiaoyu Zhu, Ph.D
Role: primary
Yue Wu, M.D
Role: backup
Other Identifiers
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coenzyme I for injection
Identifier Type: -
Identifier Source: org_study_id