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Recruiting NCT06558253

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

Phase I Interventional Hematopoietic Recovery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coenzyme I for Injection.
Who it may be relevant to
Registry conditions: Hematopoietic Recovery. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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 d

Primary outcome measures

  • Adverse Event(AE) [Time frame: From the date of initial treatment to 30 days after transplantation]
Secondary outcome measures (11)
  • Neutrophil engraftment time [Time frame: 42 days post transplantation]
  • Cumulative incidence of neutrophil engraftment on day 16 [Time frame: 16 days post transplantation]
  • platelet engraftment time [Time frame: 180 days post transplantation]
  • Cumulative incidence of platelet engraftment on day 60 [Time frame: 60 days post transplantation]
  • Cumulative incidence of primary graft failure on day 30 [Time frame: 30 days post transplantation]
  • Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100 [Time frame: 100 days post transplantation]
  • Cumulative incidence of transplant-related mortality on day 180 [Time frame: 180 days post transplantation]
  • Cumulative incidence of relapse on day 180 [Time frame: 180 days post transplantation]
  • Probability of overall survival [Time frame: 180 days post transplantation]
  • Probability of leukemia-free survival [Time frame: 180 days post transplantation]
  • Probability of GVHD-free relapse-free survival [Time frame: 180 days post transplantation]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of University of Science and Technology of China (Anhui Prov — Hefei

Identifiers

NCT: NCT06558253 · coenzyme I for injection

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗