Clinical trial · Interventional
Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT
Efficacy and Safety of a Long-acting Thrombopoietin Receptor Agonist for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing Umbilical Cord Blood Transplantation
NCT06693791CI-TRIAL-00082635recruitingPhase 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)
To evaluate the efficacy and safety of Romiplostim N01 for platelet recovery after umbilical cord blood transplantation (UCBT) in patients with 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 |
|---|---|---|---|
| Platelet Recovery After Umbilical Cord Blood Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Romiplostim N01 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Romiplostim N01
- interventionNames
- Drug: Romiplostim N01
Primary outcomes (2)
- measure
- Time of platelet engraftment
- timeFrame
- 28 days
- description
- Platelet engraftment is defined as independence from platelet transfusion for at least 7 days with a platelet count of more than ≥20 × 10\^9/L.
- measure
- The cumulative incidence of platelet engraftment at 28 days after transplantation
- timeFrame
- 28 days
- description
- Platelet engraftment is defined as independence from platelet transfusion for at least 7 days with a platelet count of more than ≥20 × 10\^9/L.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥12 years old, male or female; * Patients diagnosed with hematological malignancies and undergoing UCBT; * ECOG score ≤2; * Voluntary participation in this clinical trial, patients fully understand the trial content and sign the informed consent Exclusion Criteria: * Pregnant or lactating women; * Known allergy to Romiplostim N01; * A history of severe thrombotic events or known risk factors for thrombosis or active thromboembolism requiring anticoagulation; * A history of platelet dysfunction or bleeding prone disease or severe bleeding (requiring more than 2 units of red blood cell infusion or a hematocrit drop of ≥10%) within 7 days prior to screening; * Chronic active hepatitis B and C; * Repeat or multiple transplantation or multiple organ transplantation; * HIV positive, EBV-DNA positive, CMV-DNA positive; * Have severe infection or complicated with serious heart, liver, lung, kidney, neurological or metabolic diseases; * A serious adverse event (Level 4 or 5) as defined by the Standard General Terminology for Adverse Events Version 4.0 occurred during the pre-treatment period; * Participants participate in another clinical study with any exploratory drug or device within 30 days prior to baseline visit; Observational studies are allowed; * Subjects with cognitive impairment or uncontrolled mental illness; * Subjects and/or authorized family members to refuse treatment with Romiplostim N01; * Those who are judged by the researchers as not suitable for inclusion (such as accompanying medical history, which may affect the safety of the subjects or it is estimated that the treatment cannot be adhered to due to financial problems).
References
Publications (0)
Data not yet available
No reference posted for this study.