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NCT02046291
Safety of Romiplostim (Nplate®) Following UCBT
Phase 1 trial testing Romiplostim in Hematologic Malignancies in 21 participants. Completed in 1 June 2021.
12 December 2020
Quick facts
| Lead sponsor | Masonic Cancer Center, University of Minnesota |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 21 |
| Start date | 10 April 2015 |
| Primary completion | 12 December 2020 |
| Estimated completion | 1 June 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Romiplostim (ROMIPLOSTIM) — full drug profile →
Conditions studied
- Hematologic Malignancies — all drugs for Hematologic Malignancies →
Sponsor
Masonic Cancer Center, University of Minnesota
Who can join
18 and older, any sex, with Hematologic Malignancies. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Phase I Dose-Finding, Safety, and Tolerability Trial of Romiplostim to Improve Platelet Recovery After UCB Transplantation.
Christakopoulos GE, DeFor TE, Hage S, Wagner JE, et al · · 2021 · cited 12× · PMID 33785364 · DOI 10.1016/j.jtct.2021.02.033 -
Alternatives, and adjuncts, to prophylactic platelet transfusion for people with haematological malignancies undergoing intensive chemotherapy or stem cell transplantation.
Desborough M, Estcourt LJ, Doree C, Trivella M, et al · · 2016 · cited 10× · PMID 27548292 · DOI 10.1002/14651858.cd010982.pub2 -
Efficacy and Immunomodulating Properties of Eltrombopag in Aplastic Anemia following Autologous Stem Cell Transplant: Case Report and Review of the Literature.
Bortolotti M, Pettine L, Zaninoni A, Croci GA, et al · · 2022 · cited 6× · PMID 35455416 · DOI 10.3390/ph15040419
Verify or expand the search:
- PubMed search for NCT02046291
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Romiplostim
Trials testing the same drug.
- NCT07001254 — UI-Romi-02; Romiplostim Added to Standard of Care for Treatment Naive and Relapsed or Refractory Severe Aplastic Anemia · Phase 2 · not yet recruiting
- NCT07400341 — Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA · Phase 2 · recruiting
- NCT06345495 — High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly · Phase 2 · recruiting
- NCT07003256 — Observational Study: Romiplostim for Platelet Recovery in Haploidentical HSCT · enrolling by invitation
- NCT06535685 — A Study of Romiplostim for the Treatment of Refractory Transfusion-dependent NSAA · Phase 4 · not yet recruiting
Other recruiting trials for Hematologic Malignancies
Currently open trials in the same condition.
- NCT04546945 — Aberrant Expression of CD56 in Patients With Hematologic Malignancies. · recruiting
- NCT06926595 — Allogeneic HSCT With Low-Dose Post-Transplant Cyclophosphamide for GVHD Prevention · Phase 2 · recruiting
- NCT07186192 — Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor (CAR-T) Therapy · Phase 3 · recruiting
- NCT07195916 — A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies · Phase 1 · recruiting
- NCT07162038 — Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA- · Phase 1 · recruiting
Other Masonic Cancer Center, University of Minnesota trials
Trials by the same sponsor.
- NCT06772090 — Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies · NA · not yet recruiting
- NCT06584929 — Rural Smoking Cessation · NA · not yet recruiting
- NCT07153016 — LEgal Guidance and AdvocaCY for CAREgivers (LEGACY CARE): A Pilot Clinical Trial for Caregivers of Persons With Colorect · NA · recruiting
- NCT06792825 — HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL · Phase 2 · recruiting
- NCT07070726 — UNTOLD Ovarian Cancer Unmet Needs Survey · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02046291 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Masonic Cancer Center, University of Minnesota
- Last refreshed: 8 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02046291.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing