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NCT Number: NCT06558253

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Adverse Event(AE)

    Time frame: From the date of initial treatment to 30 days after transplantation

    Number of treatment-related adverse events as assessed by CTCAE v5.0

Secondary outcomes

  1. Neutrophil engraftment time

    Time frame: 42 days post transplantation

    The first day of absolute neutrophil count ≥ 0.5×10^9/L for 3 consecutive days post transplantation.

  2. Cumulative incidence of neutrophil engraftment on day 16

    Time frame: 16 days post transplantation

    Cumulative incidence of neutrophil engraftment on day 16 post transplantation.

  3. platelet engraftment time

    Time frame: 180 days post transplantation

    The first day of platelet count ≥ 20×10^9/L for 7 consecutive days without platelet transfusions for 7 consecutive days post transplantation.

  4. Cumulative incidence of platelet engraftment on day 60

    Time frame: 60 days post transplantation

    Cumulative incidence of platelet engraftment on day 60 post transplantation.

  5. Cumulative incidence of primary graft failure on day 30

    Time frame: 30 days post transplantation

    Cumulative incidence of primary graft failure on day 30 post transplantation.

  6. Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100

    Time frame: 100 days post transplantation

    Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100 post transplantation.

  7. Cumulative incidence of transplant-related mortality on day 180

    Time frame: 180 days post transplantation

    Cumulative incidence of transplant-related mortality on day 180 post transplantation.

  8. Cumulative incidence of relapse on day 180

    Time frame: 180 days post transplantation

    Cumulative incidence of relapse on day 180 post transplantation.

  9. Probability of overall survival

    Time frame: 180 days post transplantation

    Probability of overall survival on day 180 post transplantation.

  10. Probability of leukemia-free survival

    Time frame: 180 days post transplantation

    Probability of leukemia-free survival on day 180 post transplantation.

  11. Probability of GVHD-free relapse-free survival

    Time frame: 180 days post transplantation

    Probability of GVHD-free relapse-free survival on day 180 post transplantation.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoyu Zhu, Ph.D

CONTACT

[email protected]

15255456091

Yue Wu, M.D

CONTACT

[email protected]

13805601119

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.