Chemotherapy Supported by Autologous Hematopoietic Stem Cells

NCT ID: NCT05401162

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2027-05-31

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

transfusion of autologous blood containing haematopoietic stem cells after conventional chemotherapy

Group Type: EXPERIMENTAL

Autologous blood transfusion with haematopoietic stem cells

Intervention Type: OTHER

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.

Control group

enrolled ovarian cancer patients receive conventional chemotherapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chongqing University Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dongling Zou, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chongqing University Cancer Hospital

Locations

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dongling Zou, M.D.

Role: CONTACT

cqzl_zdl@163.com

13657690699

Facility Contacts

Dongling Zou, M.D.

Role: primary

cqzl_zdl@163.com

13657690699

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

CQGOG0203

Identifier Type: -

Identifier Source: org_study_id