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Chemotherapy Supported by Autologous Hematopoietic Stem Cells

Primary Purpose

Ovarian Cancer

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Autologous blood transfusion with haematopoietic stem cells

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian Cancer, Conventional chemotherapy, blood stem cells, autologous blood transfusion

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

1）18-60 years old; 2)there are chemotherapy indicators for ovarian cancer;3)ovarian cancer diagnosed by histopathology;4)recurrent and metastatic ovarian cancer;5)the Eastern Cooperative Oncology Group (ECOG) performance status score≤1;6)the expected survival time was more than 3 months; 7)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;8)all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;9)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;10)bone marrow function is good,ability to perform stem cell mobilisation and collection.

Exclusion Criteria:

1) patients with bone marrow disease;2)central nervous system or soft meningeal or bone or bone marrow metastases confirmed by imaging or pathology;3)patient has severe cardiac insufficiency;4)previous history of allogeneic stem cell transplantation or organ transplantation;5)patients with active bleeding and autoimmune thrombocytopenic purpura;6)patients with chemotherapy contraindications;7)positive for human immunodeficiency virus (HIV);8)acute or chronic active hepatitis B or hepatitis C infection.

Sites / Locations

Chongqing University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

transfusion of autologous blood containing haematopoietic stem cells after conventional chemotherapy

enrolled ovarian cancer patients receive conventional chemotherapy

Outcomes

Primary Outcome Measures

Incidence of Grade 3-4 neutropenia

Time to reconstruct haematopoietic function

Incidence of febrile neutropenia (FN)

Secondary Outcome Measures

the rate of postponement of the course for chemotherapy

reduction in chemotherapy dose

Safety of hematopoietic stem cell reinfusion therapy

Safety of hematopoietic stem cell reinfusion therapy(adverse events)

Full Information

NCT ID

NCT05401162

First Posted

May 29, 2022

Last Updated

May 29, 2022

Sponsor

Chongqing University Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05401162

Brief Title

Chemotherapy Supported by Autologous Hematopoietic Stem Cells

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 15, 2022 (Actual)

Primary Completion Date

May 2025 (Anticipated)

Study Completion Date

May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chongqing University Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer

Keywords

Ovarian Cancer, Conventional chemotherapy, blood stem cells, autologous blood transfusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

transfusion of autologous blood containing haematopoietic stem cells after conventional chemotherapy

Arm Title

Control group

Arm Type

No Intervention

Arm Description

enrolled ovarian cancer patients receive conventional chemotherapy

Intervention Type

Other

Intervention Name(s)

Autologous blood transfusion with haematopoietic stem cells

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of Grade 3-4 neutropenia

Description

Incidence of Grade 3-4 neutropenia

Time Frame

8 months

Title

Time to reconstruct haematopoietic function

Description

Time to reconstruct haematopoietic function

Time Frame

8 months

Title

Incidence of febrile neutropenia (FN)

Description

Incidence of febrile neutropenia (FN)

Time Frame

8 months

Secondary Outcome Measure Information:

Title

the rate of postponement of the course for chemotherapy

Description

the rate of postponement of the course for chemotherapy

Time Frame

8 months

Title

reduction in chemotherapy dose

Description

reduction in chemotherapy dose

Time Frame

6 months

Title

Safety of hematopoietic stem cell reinfusion therapy

Description

Safety of hematopoietic stem cell reinfusion therapy(adverse events)

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1）18-60 years old; 2)there are chemotherapy indicators for ovarian cancer;3)ovarian cancer diagnosed by histopathology;4)recurrent and metastatic ovarian cancer;5)the Eastern Cooperative Oncology Group (ECOG) performance status score≤1;6)the expected survival time was more than 3 months; 7)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;8)all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;9)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;10)bone marrow function is good,ability to perform stem cell mobilisation and collection. Exclusion Criteria: 1) patients with bone marrow disease;2)central nervous system or soft meningeal or bone or bone marrow metastases confirmed by imaging or pathology;3)patient has severe cardiac insufficiency;4)previous history of allogeneic stem cell transplantation or organ transplantation;5)patients with active bleeding and autoimmune thrombocytopenic purpura;6)patients with chemotherapy contraindications;7)positive for human immunodeficiency virus (HIV);8)acute or chronic active hepatitis B or hepatitis C infection.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dongling Zou, M.D.

Phone

13657690699

cqzl_zdl@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dongling Zou, M.D.

Organizational Affiliation

Chongqing University Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chongqing University Cancer Hospital

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dongling Zou, M.D.

Phone

13657690699

cqzl_zdl@163.com

First Name & Middle Initial & Last Name & Degree

Dongling Zou, M.D.

First Name & Middle Initial & Last Name & Degree

Yao Liu, M.D.

First Name & Middle Initial & Last Name & Degree

Na Zhang, M.M.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28958156

Citation

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.

Results Reference

background

PubMed Identifier

21943360

Citation

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.

Results Reference

background

PubMed Identifier

15107813

Citation

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.

Results Reference

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PubMed Identifier

15108043

Citation

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.

Results Reference

background

PubMed Identifier

9586901

Citation

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.

Results Reference

background

PubMed Identifier

18026149

Citation

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.

Results Reference

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PubMed Identifier

10849525

Citation

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.

Results Reference

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Chemotherapy Supported by Autologous Hematopoietic Stem Cells

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