Clinical trial · Interventional
Chemotherapy Supported by Autologous Hematopoietic Stem Cells
Conventional Dose Chemotherapy for Ovarian Cancer Supported by Autologous Haematopoietic Stem Cell Transfusion
NCT05401162CI-TRIAL-00116239recruitingN/AClinicalTrials.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)
The aim of this project is to use autologous haematopoietic stem cell transfusion support to promote the reconstruction of haematopoietic function after chemotherapy for ovarian cancer. To explore the impact of stored haematopoietic stem cell support therapy on bone marrow protection after conventional chemotherapy for ovarian cancer in order to facilitate its clinical application.
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 |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous blood transfusion with haematopoietic stem cells | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- transfusion of autologous blood containing haematopoietic stem cells after conventional chemotherapy
- interventionNames
- Other: Autologous blood transfusion with haematopoietic stem cells
- type
- NO_INTERVENTION
- label
- Control group
- description
- enrolled ovarian cancer patients receive conventional chemotherapy
Primary outcomes (3)
- measure
- Incidence of Grade 3-4 neutropenia
- timeFrame
- 8 months
- description
- Incidence of Grade 3-4 neutropenia
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 18-60 years old; * there are chemotherapy indicators for ovarian cancer; * ovarian cancer diagnosed by histopathology; * recurrent and metastatic ovarian cancer; * the Eastern Cooperative Oncology Group (ECOG) performance status score≤1; * the expected survival time was more than 3 months; * pre-menopausal women (post-menopausal women must have been postmenopausal for at least 12 months to be considered infertile), and the serum pregnancy test results are negative; * all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment; * the subjects voluntarily participate in this clinical trial sign an informed consent form and are able to complete the study procedures and follow-up examinations; * bone marrow function is good,ability to perform stem cell mobilisation and collection. Exclusion Criteria: * patients with bone marrow disease; * central nervous system or soft meningeal or bone or bone marrow metastases confirmed by imaging or pathology; * patient has severe cardiac insufficiency; * previous history of allogeneic stem cell transplantation or organ transplantation; * patients with active bleeding and autoimmune thrombocytopenic purpura; * patients with chemotherapy contraindications; * positive for human immunodeficiency virus (HIV); * acute or chronic active hepatitis B or hepatitis C infection.
References
Publications (7)
- BACKGROUNDWeycker D, Bensink M, Wu H, Doroff R, Chandler D. Risk of chemotherapy-induced febrile neutropenia with early discontinuation of pegfilgrastim prophylaxis based on real-world data from 2010 to 2015. Curr Med Res Opin. 2017 Dec;33(12):2115-2120. doi: 10.1080/03007995.2017.1386638. Epub 2017 Oct 16. PMID 28958156
- BACKGROUNDCooper KL, Madan J, Whyte S, Stevenson MD, Akehurst RL. Granulocyte colony-stimulating factors for febrile neutropenia prophylaxis following chemotherapy: systematic review and meta-analysis. BMC Cancer. 2011 Sep 23;11:404. doi: 10.1186/1471-2407-11-404. PMID 21943360
- BACKGROUNDMagagnoli M, Masci G, Castagna L, Rimassa L, Bramanti S, Santoro A. Intermediate-dose melphalan with stem-cell support in platinum-refractory ovarian cancer. Bone Marrow Transplant. 2004 Jun;33(12):1261-2. doi: 10.1038/sj.bmt.1704527. No abstract available. PMID 15107813
- BACKGROUNDIkeba K, Okubo M, Takeda S, Kinoshita K, Maeda H. Five-year results of cyclic semi-high dose neoadjuvant chemotherapy supported by autologous peripheral blood stem-cell transplantation in patients with advanced ovarian cancer. Int J Clin Oncol. 2004 Apr;9(2):113-9. doi: 10.1007/s10147-003-0377-x. PMID 15108043
- BACKGROUNDAghajanian C, Fennelly D, Shapiro F, Waltzman R, Almadrones L, O'Flaherty C, O'Conner K, Venkatraman E, Barakat R, Curtin J, Brown C, Reich L, Wuest D, Norton L, Hoskins W, Spriggs DR. Phase II study of "dose-dense" high-dose chemotherapy treatment with peripheral-blood progenitor-cell support as primary treatment for patients with advanced ovarian cancer. J Clin Oncol. 1998 May;16(5):1852-60. doi: 10.1200/JCO.1998.16.5.1852. PMID 9586901
- BACKGROUNDPapadimitriou C, Dafni U, Anagnostopoulos A, Vlachos G, Voulgaris Z, Rodolakis A, Aravantinos G, Bamias A, Bozas G, Kiosses E, Gourgoulis GM, Efstathiou E, Dimopoulos MA. High-dose melphalan and autologous stem cell transplantation as consolidation treatment in patients with chemosensitive ovarian cancer: results of a single-institution randomized trial. Bone Marrow Transplant. 2008 Mar;41(6):547-54. doi: 10.1038/sj.bmt.1705925. Epub 2007 Nov 19.