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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic Recovery
• Intervention / Treatment: Drug: Coenzyme I for Injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xiaoyu Zhu, Ph.D; Phone Number: 15255456091; Email: xiaoyuz@ustc.edu.cn
• Study Contact Backup: Name: Yue Wu, M.D; Phone Number: 13805601119; Email: 287109658@qq.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230036
      • Recruiting
      • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
      • Contact: Xiaoyu Zhu, Ph.D; Phone Number: 15255456091; Email: xiaoyuz@ustc.edu.cn
      • Contact: Yue Wu, M.D; Phone Number: 13805601119; Email: 287109658@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Coenzyme I for Injection; Subjects received 21 consecutive days of intravenous infusion of Coenzyme I for injection with three dose groups.

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Investigators: Principal Investigator: Xiaoyu Zhu, Ph.D, The First Affiliated Hospital of University of Science and Technology of China

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Hematopoietic recovery, sUCBT
• Other Study ID Numbers: coenzyme I for injection

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No