The Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery of Patients After sUCBT

NCT06558253 | Recruiting Phase 1 DMC

• 1 other identifier: coenzyme I for injection
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Recovery

Keywords

Hematopoietic recovery, sUCBT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Neutrophil engraftment time

  42 days post transplantation

• Cumulative incidence of neutrophil engraftment on day 16

  16 days post transplantation

• platelet engraftment time

  180 days post transplantation

• Cumulative incidence of platelet engraftment on day 60

  60 days post transplantation

• Cumulative incidence of primary graft failure on day 30

  30 days post transplantation

Study Arms (1)

Coenzyme I for Injection

EXPERIMENTAL

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

Drug: Coenzyme I for Injection

Interventions

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.

Coenzyme I for Injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, 230036, China

RECRUITING

MeSH Terms

Interventions

NAD; Injections

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Xiaoyu Zhu, Ph.D

  The First Affiliated Hospital of University of Science and Technology of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyu Zhu, Ph.D

CONTACT

15255456091; xiaoyuz@ustc.edu.cn

Yue Wu, M.D

CONTACT

13805601119; 287109658@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: November 29, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

CN (1)