Clinical trial · Interventional
The Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery of Patients After sUCBT
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
NCT06558253CI-TRIAL-00083867recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic Recovery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Coenzyme I for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Coenzyme I for Injection
- description
- Subjects received 21 consecutive days of intravenous infusion of Coenzyme I for injection with three dose groups.
- interventionNames
- Drug: Coenzyme I for Injection
Primary outcomes (1)
- measure
- Adverse Event(AE)
- timeFrame
- From the date of initial treatment to 30 days after transplantation
- description
- Number of treatment-related adverse events as assessed by CTCAE v5.0
Secondary outcomes (11)
- measure
- Neutrophil engraftment time
- timeFrame
- 42 days post transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.