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Ovarian CancerNCT05401162

Chemotherapy Supported by Autologous Hematopoietic Stem Cells

A study testing Autologous blood transfusion with haematopoietic stem cells in people with Ovarian Cancer, run by Chongqing University Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Autologous blood transfusion with haematopoietic stem cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
15 Apr 2022to May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dongling Zou, M.D. contact

13657690699

cqzl_zdl@163.com

China1 site, 1 recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Dongling Zou, M.D., 13657690699, cqzl_zdl@163.com

    Dongling Zou, M.D.

    Recruiting

Other trials in China

About this study

Official title: Conventional Dose Chemotherapy for Ovarian Cancer Supported by Autologous Haematopoietic Stem Cell Transfusion

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.

Read the detailed description

Study design:In this prospective, single-center,non-randomised controlled study, patients with ovarian cancer were divided into two groups. The patients in the experimental group received autologous blood transfusion containing hematopoietic stem cells 1 day after conventional chemotherapy, while the control group only received conventional chemotherapy.

Case selection: Patients with primary ovarian cancer,ovarian cancer confirmed by histopathology, and three weeks of platinum-containing regimen chemotherapy.

Primary end point: 1)incidence and duration of grade 3/4 neutropenia in patients;2)hematopoietic reconstitution time in patients. Secondary endpoints: 1)the rate of reduction in chemotherapy dose and postponement of the course for chemotherapy;2) Incidence of febrile neutropenia (FN);3)Safety of hematopoietic stem cell reinfusion therapy (adverse events).

Safety assessment: laboratory safety testing, including platelet count,white blood cell and hemoglobin. Evaluation of adverse events: infection, neutropenic fever, hypocalcemia,anemia and thrombocytopenia,bone pain, etc.

Conditions
Ovarian Cancer
Being tested
Autologous blood transfusion with haematopoietic stem cells
Keywords
Ovarian Cancer, Conventional chemotherapy, blood stem cells, autologous blood transfusion
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous blood transfusion with haematopoietic stem cellsOther

    Transfusion of autologous blood containing haematopoietic stem cells for haematopoietic reconstruction after chemotherapy.Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during chemotherapy, G-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.Monitor peripheral blood after transfusion. If peripheral blood leukocyte count does not reach 1.0 x 109/L, administer G-CSF 150 μg subcutaneously daily until peripheral blood leukocyte count reaches 1.0 x 109/L.Patients were tested monthly for peripheral blood cells for 6 months after the end of treatment.

Study groups in NCT05401162
Study groupRoleWhat they receive
Experimental groupExperimentaltransfusion of autologous blood containing haematopoietic stem cells after conventional chemotherapy
Receives: Other: Autologous blood transfusion with haematopoietic stem cells
Control groupNo interventionenrolled ovarian cancer patients receive conventional chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Grade 3-4 neutropenia

    Incidence of Grade 3-4 neutropenia

    Measured: 8 months

  2. Time to reconstruct haematopoietic function

    Time to reconstruct haematopoietic function

    Measured: 6 months

  3. Incidence of febrile neutropenia (FN)

    Incidence of febrile neutropenia (FN)

    Measured: 8 months

Secondary outcomes (3)

  1. the rate of postponement of the course for chemotherapy

    the rate of postponement of the course for chemotherapy

    Measured: 8 months

  2. reduction in chemotherapy dose

    reduction in chemotherapy dose

    Measured: 6 months

  3. Incidence of hematopoietic stem cell reinfusion treatment Adverse Events [Safety and Tolerability]

    Incidence of hematopoietic stem cell reinfusion treatment Adverse Events [Safety and Tolerability]

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2022
  2. Study start15 Apr 2022
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05401162
Sponsor's protocol ID
CQGOG0203
Status last verified
Jun 2026
First submitted
29 May 2022
Last updated
29 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Weycker 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.

    PubMed 28958156

  • Cooper 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.

    PubMed 21943360

  • Magagnoli 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.

    PubMed 15107813

  • Ikeba 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.

    PubMed 15108043

  • Aghajanian 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.

    PubMed 9586901

  • Papadimitriou 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.

    PubMed 18026149

  • Donato ML, Gershenson D, Ippoliti C, Wharton JT, Bast RC Jr, Aleman A, Anderlini P, Gajewski JG, Giralt S, Molldrem J, Ueno N, Lauppe J, Korbling M, Boyer J, Bodurka-Bevers D, Bevers M, Burke T, Freedman R, Levenback C, Wolf J, Champlin RE. High-dose ifosfamide and etoposide with filgrastim for stem cell mobilization in patients with advanced ovarian cancer. Bone Marrow Transplant. 2000 Jun;25(11):1137-40. doi: 10.1038/sj.bmt.1702421.

    PubMed 10849525

Questions about this trial

What is this clinical trial studying?

A study testing Autologous blood transfusion with haematopoietic stem cells in people with Ovarian Cancer, run by Chongqing University Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dongling Zou, M.D. (13657690699, cqzl_zdl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Grade 3-4 neutropenia (time frame: 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05401162, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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