Chemotherapy Supported by Autologous Hematopoietic Stem Cells

May 29, 2022 updated by: Chongqing University Cancer Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital
        • Principal Investigator:
          • Dongling Zou, M.D.
        • Principal Investigator:
          • Yao Liu, M.D.
        • Sub-Investigator:
          • Na Zhang, M.M.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
transfusion of autologous blood containing haematopoietic stem cells after conventional chemotherapy
Other: Autologous blood transfusion with haematopoietic stem cells
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.
No Intervention: Control group
enrolled ovarian cancer patients receive conventional chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Grade 3-4 neutropenia
Time Frame: 8 months
Incidence of Grade 3-4 neutropenia
8 months
Time to reconstruct haematopoietic function
Time Frame: 8 months
Time to reconstruct haematopoietic function
8 months
Incidence of febrile neutropenia (FN)
Time Frame: 8 months
Incidence of febrile neutropenia (FN)
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of postponement of the course for chemotherapy
Time Frame: 8 months
the rate of postponement of the course for chemotherapy
8 months
reduction in chemotherapy dose
Time Frame: 6 months
reduction in chemotherapy dose
6 months
Safety of hematopoietic stem cell reinfusion therapy
Time Frame: 3 months
Safety of hematopoietic stem cell reinfusion therapy(adverse events)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing University Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2022

Primary Completion (Anticipated)

May 1, 2025

Study Completion (Anticipated)

May 1, 2027

Study Registration Dates

First Submitted

May 29, 2022

First Submitted That Met QC Criteria

May 29, 2022

First Posted (Actual)

June 2, 2022

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 29, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQGOG0203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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