The Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery of Patients After sUCBT
An Exploratory Study to Assess the Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery After Single-unit Unrelated Cord Blood Transplantation in Patients With Hematological Malignancies
Anhui Provincial Hospital
12 participants
Nov 29, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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).
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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.
Locations(1)
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NCT06558253