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NCT03878199
Testing the Effect of Taking Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms
Phase 1, PHASE2 trial testing Allogeneic Hematopoietic Stem Cell Transplantation in Essential Thrombocythemia in 12 participants. Completed in 27 February 2025.
27 February 2025
Quick facts
| Lead sponsor | Ohio State University Comprehensive Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 20 February 2019 |
| Primary completion | 27 February 2025 |
| Estimated completion | 27 February 2025 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Allogeneic Hematopoietic Stem Cell Transplantation — full drug profile →
- Liposome-encapsulated Daunorubicin-Cytarabine — full drug profile →
- Ruxolitinib (RUXOLITINIB) — full drug profile →
Conditions studied
- Essential Thrombocythemia — all drugs for Essential Thrombocythemia →
- Myelofibrosis — all drugs for Myelofibrosis →
- Myeloproliferative Neoplasm — all drugs for Myeloproliferative Neoplasm →
- Polycythemia Vera — all drugs for Polycythemia Vera →
Sponsor
Ohio State University Comprehensive Cancer Center
Who can join
18 and older, any sex, with Essential Thrombocythemia or Myelofibrosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I/II trial studies the best dose of ruxolitinib when given together with CPX-351 and to see how well they work in treating patients with accelerated phase or blast phase myeloproliferative neoplasm. Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. CPX-351 is a mixture of 2 chemotherapy drugs (daunorubicin and cytarabine) given for leukemia in small fat-based particles (liposomes) to improve the drug getting into cancer cells. Giving ruxolitinib and CPX-351 may work better in treating patients with secondary acute myeloid leukemia compared to CPX-351 alone.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Progression of Myeloproliferative Neoplasms (MPN): Diagnostic and Therapeutic Perspectives.
Baumeister J, Chatain N, Sofias AM, Lammers T, et al · · 2021 · cited 50× · PMID 34944059 · DOI 10.3390/cells10123551 -
JAK/STAT in leukemia: a clinical update.
Liang D, Wang Q, Zhang W, Tang H, et al · · 2024 · cited 38× · PMID 38273387 · DOI 10.1186/s12943-023-01929-1 -
Nanocarriers as Magic Bullets in the Treatment of Leukemia.
Houshmand M, Garello F, Circosta P, Stefania R, et al · · 2020 · cited 35× · PMID 32041219 · DOI 10.3390/nano10020276 -
The Interplay Between the Genetic and Immune Landscapes of AML: Mechanisms and Implications for Risk Stratification and Therapy.
Mendez LM, Posey RR, Pandolfi PP. · · 2019 · cited 31× · PMID 31781488 · DOI 10.3389/fonc.2019.01162 -
Untwining Anti-Tumor and Immunosuppressive Effects of JAK Inhibitors-A Strategy for Hematological Malignancies?
Klein K, Stoiber D, Sexl V, Witalisz-Siepracka A. · · 2021 · cited 22× · PMID 34073410 · DOI 10.3390/cancers13112611 -
JAK inhibitors and black box warnings: what is the future for JAK inhibitors?
Tokareva K, Reid P, Yang V, Liew D, et al · · 2023 · cited 20× · PMID 37596779 · DOI 10.1080/1744666x.2023.2249237 -
Single-agent and combination biologics in acute myeloid leukemia.
Richard-Carpentier G, DiNardo CD. · · 2019 · cited 18× · PMID 31808888 · DOI 10.1182/hematology.2019000059 -
Targeting Approaches of Nanomedicines in Acute Myeloid Leukemia.
Huang X, Lin H, Huang F, Xie Y, et al · · 2019 · cited 17× · PMID 31853234 · DOI 10.1177/1559325819887048
Verify or expand the search:
- PubMed search for NCT03878199
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07228624 — Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplas · Phase 2 · recruiting
Other recruiting trials for Essential Thrombocythemia
Currently open trials in the same condition.
- NCT06661915 — A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs) · Phase 2 · recruiting
- NCT06734637 — Efficacy and Safety of Peginterferon in ET and PV. · NA · recruiting
- NCT06456346 — Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007) · Phase 3 · recruiting
- NCT06361641 — Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes · NA · recruiting
- NCT06378437 — A Study of GLB-001 in Patients With Myeloid Malignancies · Phase 1 · recruiting
Other Ohio State University Comprehensive Cancer Center trials
Trials by the same sponsor.
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- NCT07455513 — A Novel Tobacco Cessation Resource for Smokers With a Diagnosed or Suspected Thoracic Cancer · NA · not yet recruiting
- NCT07217990 — Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer · Phase 1, PHASE2 · not yet recruiting
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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 NCT03878199 (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 Ohio State University Comprehensive Cancer Center
- Last refreshed: 15 September 2025
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