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NCT03294577
Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia
Phase 3 trial testing Pegfilgrastim in Chemotherapy-induced Neutropenia in 221 participants. Status unknown.
25 September 2020
Quick facts
| Lead sponsor | BeyondSpring Pharmaceuticals Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 221 |
| Start date | 23 October 2019 |
| Primary completion | 25 September 2020 |
| Estimated completion | 25 September 2025 |
| Sites | 20 locations across China, Ukraine |
Drugs / interventions tested
- Pegfilgrastim (PEGFILGRASTIM) — full drug profile →
- Plinabulin — full drug profile →
- D5W Placebo
- Docetaxel, doxorubicin, and cyclophosphamide (TAC) — full drug profile →
Conditions studied
- Chemotherapy-induced Neutropenia — all drugs for Chemotherapy-induced Neutropenia →
Sponsor
BeyondSpring Pharmaceuticals Inc. — full company profile →
Who can join
18 and older, female only, with Chemotherapy-induced Neutropenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary purpose of this study is to compare the percentage of patients with Duration of Severe Neutropenia (DSN) =0 in patients treated with: Docetaxel, doxorubicin, and cyclophosphamide (TAC) + pegfilgrastim versus Docetaxel, doxorubicin, and cyclophosphamide (TAC) + combination plinabulin/pegfilgrastim Severe neutropenia is an absolute neutrophil count (ANC) \<0.5 × 10\^9/L. Docetaxel, doxorubicin, and cyclophosphamide (TAC) will be used as the chemotherapy in this study.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Plinabulin, a Distinct Microtubule-Targeting Chemotherapy, Promotes M1-Like Macrophage Polarization and Anti-tumor Immunity.
Natoli M, Herzig P, Pishali Bejestani E, Buchi M, et al · · 2021 · cited 35× · PMID 33747968 · DOI 10.3389/fonc.2021.644608 -
The impact of myelosuppression on quality of life of patients treated with chemotherapy.
Crawford J, Herndon D, Gmitter K, Weiss J. · · 2024 · cited 31× · PMID 38587388 · DOI 10.2217/fon-2023-0513 -
Improving Outcomes of Chemotherapy: Established and Novel Options for Myeloprotection in the COVID-19 Era.
Lyman GH, Kuderer NM, Aapro M. · · 2021 · cited 15× · PMID 34307165 · DOI 10.3389/fonc.2021.697908 -
Potential role of marine species-derived bioactive agents in the management of SARS-CoV-2 infection.
Asif M, Saleem M, Yaseen HS, Yehya AH, et al · · 2021 · cited 5× · PMID 34689597 · DOI 10.2217/fmb-2021-0024 -
1715P Plinabulin (Plin) is a more favorable option for the prevention of chemotherapy induced neutropenia (CIN) than pegfilgrastim (Peg) during the COVID-19 pandemic
Blayney D, Mohanlal R, Huang L. · · 2020
Verify or expand the search:
- PubMed search for NCT03294577
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Chemotherapy-induced Neutropenia
Currently open trials in the same condition.
- NCT06809101 — Home Monitoring of Complete Blood Count Performed by Patients - a Pilot Study on the Implementation Process in South Bal · recruiting
- NCT06537726 — Breath Analysis for the Detection of Invasive Fungal Infections · recruiting
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Other BeyondSpring Pharmaceuticals Inc. trials
Trials by the same sponsor.
- NCT07361484 — Docetaxel Plus Plinabulin vs Docetaxel Plus Placebo in Advanced/Metastatic Non-Squamous NSCLC After PD-1/PD-L1 Therapy a · Phase 3 · not yet recruiting
- NCT03102606 — Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3 · Phase 3 · completed
- NCT04227990 — Plinabulin iv Solution in Prevention of TAC Induced Neutropenia · Phase 2 · completed
- NCT04345900 — Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 2 · Phase 2 · completed
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 NCT03294577 (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 BeyondSpring Pharmaceuticals Inc.
- Last refreshed: 15 January 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/NCT03294577.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing