Clinical trial · Interventional
Effectiveness and Safety of a Single-Center Clinical Study on a CD25 Monoclonal Antibody-Containing GVHD Prophylaxis Scheme to Reduce the Incidence of Severe Acute GVHD After Umbilical Cord Blood Transplantation for Malignant Hematologic Diseases
NCT06480630CI-TRIAL-00078372not yet recruitingPhase 2ClinicalTrials.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)
Evaluating the safety and effectiveness of a CD25 monoclonal antibody-based prophylactic acute graft-versus-host-disease (aGVHD) regimen following unrelated umbilical cord blood transplantation (UCBT) for malignant hematologic disorders in reducing severe aGVHD.
Conditions
Conditions (2)
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 | — |
| Malignant Hematologic Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Basiliximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- basiliximab group
- interventionNames
- Drug: Basiliximab
Primary outcomes (1)
- measure
- The cumulative incidence of grade III-IV acute graft-versus-host disease (aGVHD)
- timeFrame
- within 100 days post-UCBT
- description
- The primary endpoint of the study will be the development of aGVHD in the first 100 days post-transplant. Acute GVHD was graded according to the International Consortium criteria.
Secondary outcomes (10)
- measure
- The incidence rate and occurrence time of pre-engraftment syndrome (PES)
- timeFrame
- within 30 days post-UCBT
- description
- The occurrence time and cumulative incidence of PES within 30 days post-UCBT. The PES was diagnosed according to the criteria of engraftment syndrome (ES) .
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Malignant hematologic disorders; * Patients undergoing UCBT; * Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception during treatment and for the following year. Exclusion Criteria: * Non-malignant hematologic disorders; * History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation; * Uncontrolled bacterial, viral, or fungal infections. "Uncontrolled" is defined as lack of clinical improvement or progression despite adequate antimicrobial therapy; * HIV infection or active hepatitis B or C virus infection; * Pregnant or lactating women; * Substance abusers; subjects with uncontrolled psychiatric disorders; individuals with cognitive dysfunction; * Participation in similar clinical studies within the past 3 months; * Subjects deemed unsuitable by the investigator (e.g., those expected to be unable to adhere to treatment due to financial constraints).
References
Publications (0)
Data not yet available
No reference posted for this study.