Hematopoietic RecoveryPhase 1NCT06558253
The Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery of Patients After sUCBT
A Phase 1 study testing Coenzyme I for Injection in people with Hematopoietic Recovery, run by Anhui Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hematopoietic Recovery
- What is being tested?
- Coenzyme I for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2024to 30 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, 230036
Xiaoyu Zhu, Ph.D, 15255456091, xiaoyuz@ustc.edu.cn
Yue Wu, M.D, 13805601119, 287109658@qq.com
About this study
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
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.
Read the 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.
- Conditions
- Hematopoietic Recovery
- Being tested
- Coenzyme I for Injection
- Keywords
- Hematopoietic recovery, sUCBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme I for InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme I for Injection | Experimental | Subjects received 21 consecutive days of intravenous infusion of Coenzyme I for injection with three dose groups. Receives: Drug: Coenzyme I for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event(AE)
Number of treatment-related adverse events as assessed by CTCAE v5.0
Measured: From the date of initial treatment to 30 days after transplantation
Secondary outcomes (11)
Neutrophil engraftment time
The first day of absolute neutrophil count ≥ 0.5×10^9/L for 3 consecutive days post transplantation.
Measured: 42 days post transplantation
Cumulative incidence of neutrophil engraftment on day 16
Cumulative incidence of neutrophil engraftment on day 16 post transplantation.
Measured: 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.
Measured: 180 days post transplantation
Cumulative incidence of platelet engraftment on day 60
Cumulative incidence of platelet engraftment on day 60 post transplantation.
Measured: 60 days post transplantation
Cumulative incidence of primary graft failure on day 30
Cumulative incidence of primary graft failure on day 30 post transplantation.
Measured: 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.
Measured: 100 days post transplantation
Cumulative incidence of transplant-related mortality on day 180
Cumulative incidence of transplant-related mortality on day 180 post transplantation.
Measured: 180 days post transplantation
Cumulative incidence of relapse on day 180
Cumulative incidence of relapse on day 180 post transplantation.
Measured: 180 days post transplantation
Probability of overall survival
Probability of overall survival on day 180 post transplantation.
Measured: 180 days post transplantation
Probability of leukemia-free survival
Probability of leukemia-free survival on day 180 post transplantation.
Measured: 180 days post transplantation
Probability of GVHD-free relapse-free survival
Probability of GVHD-free relapse-free survival on day 180 post transplantation.
Measured: 180 days post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start29 Nov 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic RecoveryStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xiaoyu Zhu, Ph.D, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558253
- Sponsor's protocol ID
- coenzyme I for injection
- Status last verified
- Dec 2024
- First submitted
- 14 Aug 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06558253
- Acronym / sponsor ID
- coenzyme I for injection
- Conditions
- Hematopoietic Recovery
- Keywords
- Hematopoietic recovery, sUCBT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coenzyme I for Injection | Experimental | Drug: Coenzyme I for InjectionSubjects received 21 consecutive days of intravenous infusion of Coenzyme I for injection with three dose groups. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme I for InjectionSubjects 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. | Drug | Coenzyme I for Injection |
Primary outcome
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
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoyu Zhu, Ph.D principal investigator
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Coenzyme I for Injection in people with Hematopoietic Recovery, run by Anhui Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyu Zhu, Ph.D (15255456091, xiaoyuz@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event(AE) (time frame: From the date of initial treatment to 30 days after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.