Clinical trial · Interventional
Safety of Romiplostim (Nplate®) Following UCBT
Safety of Romiplostim (Nplate®) in Patients Who Have Failed to Achieve Platelet Engraftment Following Umbilical Cord Blood Transplant
- 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)
This is a single institution, phase I dose escalation study of weekly romiplostim post umbilical cord blood transplantation in patients who fail to achieve platelet engraftment by day +30. Engraftment is defined as a platelet count ≥ 20 x 109/L on 3 consecutive measurements without transfusion for 7 days. Romiplostim is administered at the assigned dose as 6 weekly injections beginning by day +42 post transplant. Up to 4 dose levels (4, 6, 8, and 10 mcg/kg/dose) will be evaluated with the maximum tolerated dose (MTD) of romiplostim determined by using the Continual Reassessment Method (CRM). The goal of this CRM will be to identify 1 of the 4 dose levels which corresponds to the desired maximum toxicity rate of 20% or less.
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 |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Romiplostim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Romiplostim treatment
- description
- Romiplostim at the assigned dose will be administered subcutaneously (SQ) once a week for 6 weeks (i.e. 6 doses) unless platelet count exceeds 100 x 10\^9/L and at least 4 doses of therapy were given.After the initial dose, subsequent doses will be administered within a window of +/- 3 days.
- interventionNames
- Drug: Romiplostim
Primary outcomes (1)
- measure
- Maximum tolerated dose of romiplostim
- timeFrame
- Day +28 blood transplant (UCBT)
- description
- Measured by number of patients who have failed to achieve platelet engraftment by day +28 after a myeloablative or nonmyeloablative umbilical cord blood transplant (UCBT)
Secondary outcomes (3)
- measure
- Platelet recovery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient who has undergone a single or double umbilical cord blood transplant (UCBT) except those with primary myelofibrosis. * Those with acute leukemia must be in remission at the time of transplant * Must have achieved neutrophil engraftment (defined as an ANC \>500 for three consecutive days) and be off daily G-CSF prior to starting romiplostim. Intermittent G-CSF is allowed. * Failure to achieve platelet engraftment (defined as platelet count ≥20x10\^9/L on 3 consecutive measurements without transfusion for 7 days) by day +28 post UCBT * Between day +28 and day +42 status post myeloablative or nonmyeloablative UCBT (single or double cord blood transplant) * Age ≥ 18 years * Adequate organ function within 7 days of enrollment defined as: * Creatinine: ≤ 2.0 mg/dL * Hepatic: SGOT and SGPT \< 5 x upper limit of institutional normal (ULN) * Women of child bearing potential agree to use effective contraception during therapy and for 4 months after completion of therapy * Voluntary written consent Exclusion Criteria: * Known pregnancy - Pregnancy Category C: there are no adequate and well-controlled studies of romiplostim in pregnancy * Recurrence of AML or myelodysplastic syndrome on bone marrow evaluation done within 21 days of enrollment * Presence of clinically significant bone marrow fibrosis on the bone marrow examination immediately prior to UCBT * Patients requiring more than one platelet transfusion per day * History of an allergy to romiplostim
References
Publications (0)
Data not yet available