Clinical trial · Interventional
Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies Post UCBT
Prospective Randomized Controlled Phase III Clinical Study on the Impact of Stem Cell Infusion Timing on the Incidence of Acute Graft-versus-host Disease in Patients With Hematologic Malignancies Following Single-unit Umbilical Cord Blood Transplantation
NCT07047456CI-TRIAL-00099557recruitingPhase 3ClinicalTrials.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 observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with malignant hematologic diseases after single-unit unrelated cord blood transplantation (sUCBT).
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 |
|---|---|---|---|
| Acute Graft Versus Host Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Time of umbilical cord blood infusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- the early infused group
- description
- infused umbilical cord blood within 8 am and 9 am
- interventionNames
- Procedure: Time of umbilical cord blood infusion
- type
- SHAM_COMPARATOR
- label
- the late infused group
- description
- infused umbilical cord blood within 11:30 am and 12:30 pm
- interventionNames
- Procedure: Time of umbilical cord blood infusion
Primary outcomes (1)
- measure
- The incidence of grade III to IV aGVHD
- timeFrame
- 100 days post transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Definite diagnosis of malignant hematologic disease before transplantation, age, gender and race are not limited; * Participants were required to have achieved complete remission with negative minimal residual disease (MRD) prior to transplantation; * Participants who are proposed to receive sUCBT for the first time; * Eastern Cooperative Oncology Group (ECOG) score 0-2; * No serious organ failure and active infection; * Voluntary open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation; * Each subject must sign an informed consent form (ICF) indicating that he/ she understands the purpose and procedures of the study and is willing to participate in the study; in view of the subject's condition, if the participant's own signature is not conducive to the treatment of his/her condition, the ICF will be signed by the legal representative. Exclusion Criteria: * Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas; * Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise participant safety and put the results of the study at unnecessary risk; drug-dependent individuals; participants with uncontrolled psychiatric disorders; and individuals with cognitive dysfunction; * Participants in other clinical studies that may affect aGVHD within 3 months; * Those whom the investigator considers unsuitable for enrollment (e.g., those who anticipate that patients will not be able to adhere to the examination and treatment due to financial and other issues).
References
Publications (0)
Data not yet available
No reference posted for this study.