Clinical trial NCT06558253: The Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery of Patients After sUCBT
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hematopoietic Recovery
Keywords: Hematopoietic recovery, sUCBT
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Adverse Event(AE)
timeFrame: From the date of initial treatment to 30 days after transplantation
Secondary outcomes:
measure: Neutrophil engraftment time
timeFrame: 42 days post transplantation
measure: Cumulative incidence of neutrophil engraftment on day 16
timeFrame: 16 days post transplantation
measure: platelet engraftment time
timeFrame: 180 days post transplantation
measure: Cumulative incidence of platelet engraftment on day 60
timeFrame: 60 days post transplantation
measure: Cumulative incidence of primary graft failure on day 30
timeFrame: 30 days post transplantation
measure: Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100
timeFrame: 100 days post transplantation
measure: Cumulative incidence of transplant-related mortality on day 180
timeFrame: 180 days post transplantation
measure: Cumulative incidence of relapse on day 180
timeFrame: 180 days post transplantation
measure: Probability of overall survival
timeFrame: 180 days post transplantation
measure: Probability of leukemia-free survival
timeFrame: 180 days post transplantation
measure: Probability of GVHD-free relapse-free survival
timeFrame: 180 days post transplantation
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of University of Science and Technology of China
name: Xiaoyu Zhu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: