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

NCTNCT06558253Other idcoenzyme I for injection

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Overview

Status: Recruiting
Phase: Phase 1
Enrollment: 12 participants (estimated)
Sponsor: Anhui Provincial Hospital · Other gov
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
China
Start: 29 Nov 2024
Primary completion: 1 Apr 2026 (estimated)
Completion: 30 Sept 2026 (estimated)
First posted: 16 Aug 2024
Last update posted: 18 Dec 2024
Conditions: Hematopoietic Recovery

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2024202520262027

Ph 1
The Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery of Patients After sUCBT
NCT06558253
29 Nov 2024 to est. 30 Sept 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Coenzyme I for InjectionDrug

Arms1

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Adverse Event(AE)
Time frame · From the date of initial treatment to 30 days after transplantation
Registry description
Number of treatment-related adverse events as assessed by CTCAE v5.0

Secondary outcomes(11)

Neutrophil engraftment time
Time frame · 42 days post transplantation
Registry description
The first day of absolute neutrophil count ≥ 0.5×10\^9/L for 3 consecutive days post transplantation.
Cumulative incidence of neutrophil engraftment on day 16
Time frame · 16 days post transplantation
Registry description
Cumulative incidence of neutrophil engraftment on day 16 post transplantation.
platelet engraftment time
Time frame · 180 days post transplantation
Registry description
The first day of platelet count ≥ 20×10\^9/L for 7 consecutive days without platelet transfusions for 7 consecutive days post transplantation.
Cumulative incidence of platelet engraftment on day 60
Time frame · 60 days post transplantation
Registry description
Cumulative incidence of platelet engraftment on day 60 post transplantation.
Cumulative incidence of primary graft failure on day 30
Time frame · 30 days post transplantation
Registry description
Cumulative incidence of primary graft failure on day 30 post transplantation.
Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100
Time frame · 100 days post transplantation
Registry description
Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100 post transplantation.
Cumulative incidence of transplant-related mortality on day 180
Time frame · 180 days post transplantation
Registry description
Cumulative incidence of transplant-related mortality on day 180 post transplantation.
Cumulative incidence of relapse on day 180
Time frame · 180 days post transplantation
Registry description
Cumulative incidence of relapse on day 180 post transplantation.
Probability of overall survival
Time frame · 180 days post transplantation
Registry description
Probability of overall survival on day 180 post transplantation.
Probability of leukemia-free survival
Time frame · 180 days post transplantation
Registry description
Probability of leukemia-free survival on day 180 post transplantation.
Probability of GVHD-free relapse-free survival
Time frame · 180 days post transplantation
Registry description
Probability of GVHD-free relapse-free survival on day 180 post transplantation.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 60 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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).

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