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Hematopoietic Stem Cell-containing Autologous Blood Transfusion for Bone Marrow Protection in Patients With Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Autologous blood transfusion with haematopoietic stem cells
Sponsored by
Chongqing University Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Cervical Cancer, concurrent chemoradiotherapy, 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 radiotherapy and chemotherapy indicators for cervical cancer;3)pathological diagnosis of squamous, adenocarcinoma or adenosquamous carcinoma;4)the Eastern Cooperative Oncology Group (ECOG) performance status score≤1; 5)the expected survival time was more than 3 months; 6)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;7)all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;8)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.

Exclusion Criteria:

1) clinical diagnosis of bone marrow disease;2) imaging or pathological diagnosis of central nervous system or soft meningeal or bone or bone marrow metastases;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 radiochemotherapy contraindications;7)positive for human immunodeficiency virus (HIV);8)acute or chronic active hepatitis B or hepatitis C infection;9)History of gastrointestinal perforation and/or fistula, clinical signs or symptoms of intestinal obstruction and/or gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhoea), Crohn's disease, ulcerative colitis or chronic diarrhoea within the previous 6 months;10)evidence of an intra-abdominal pneumoperitoneum that cannot be explained by puncture or recent surgical intervention.

Sites / Locations

  • Chongqing University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Autologous blood transfusion support therapy group

Conventional treatment group

Arm Description

Bone aspiration and bone marrow examination before concurrent chemoradiotherapy.Peripheral blood stem cells were mobilized, frozen and stored before treatment. Resuscitate and reinfusion autologous peripheral blood 24 hours after completion of concurrent chemoradiotherapy.

Bone aspiration and bone marrow examination before concurrent chemoradiotherapy.Undergo standard radiotherapy for cervical cancer.

Outcomes

Primary Outcome Measures

Incidence of Grade 3-4 neutropenia
Incidence of Grade 3-4 neutropenia
Time to reconstruct haematopoietic function
Time to reconstruct haematopoietic function

Secondary Outcome Measures

the rate of postponement of the course of chemoradiotherapy
the rate of postponement of the course of chemoradiotherapy
reduction in chemotherapy dose
reduction in chemotherapy dose
Incidence of febrile neutropenia (FN)
Incidence of febrile neutropenia (FN)
Incidence of hematopoietic stem cell reinfusion treatment Adverse Events [Safety and Tolerability])
Incidence of hematopoietic stem cell reinfusion treatment Adverse Events [Safety and Tolerability])

Full Information

First Posted
May 29, 2022
Last Updated
April 27, 2023
Sponsor
Chongqing University Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05401175
Brief Title
Hematopoietic Stem Cell-containing Autologous Blood Transfusion for Bone Marrow Protection in Patients With Cervical Cancer
Official Title
Stored Hematopoietic Stem Cell-containing Autologous Blood Transfusion Therapy for Bone Marrow Protection in Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this project is to promote the reconstruction of haematopoietic function after chemoradiotherapy for cervical cancer with the innovative use of autologous haematopoietic containing stem cell blood transfusion support.To explore the effect of stored hemopoietic stem cell support therapy on bone marrow protection after concurrent chemoradiotherapy, in order to promote its clinical application.
Detailed Description
Study design:In this prospective, single-center,non-randomised controlled study, patients with cervical cancer are divided into two groups. Patients in the autologous blood transfusion support therapy group will receive autologous blood transfusion containing haematopoietic stem cells after completion of concurrent chemoradiotherapy, whereas the conventional treatment group receive concurrent chemoradiotherapy only. Frozen stored autologous peripheral blood transfusion 1 day after completion of chemoradiotherapy.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. Case selection: Patients with primary cervical cancer,squamous, adenocarcinoma or adenosquamous carcinoma cell carcinoma confirmed by histopathology, and three-week regimen of paclitaxel and platinum chemotherapy with concurrent radiotherapy. 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 postponement of the course of radiotherapy, reduction in chemotherapy dose and postponement of the course of 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
Cervical Cancer
Keywords
Cervical Cancer, concurrent chemoradiotherapy, 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
Autologous blood transfusion support therapy group
Arm Type
Experimental
Arm Description
Bone aspiration and bone marrow examination before concurrent chemoradiotherapy.Peripheral blood stem cells were mobilized, frozen and stored before treatment. Resuscitate and reinfusion autologous peripheral blood 24 hours after completion of concurrent chemoradiotherapy.
Arm Title
Conventional treatment group
Arm Type
No Intervention
Arm Description
Bone aspiration and bone marrow examination before concurrent chemoradiotherapy.Undergo standard radiotherapy for cervical cancer.
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 chemoradiotherapy.Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during chemoradiotherapy, 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
6 months
Title
Time to reconstruct haematopoietic function
Description
Time to reconstruct haematopoietic function
Time Frame
6 months
Secondary Outcome Measure Information:
Title
the rate of postponement of the course of chemoradiotherapy
Description
the rate of postponement of the course of chemoradiotherapy
Time Frame
3 months
Title
reduction in chemotherapy dose
Description
reduction in chemotherapy dose
Time Frame
3 months
Title
Incidence of febrile neutropenia (FN)
Description
Incidence of febrile neutropenia (FN)
Time Frame
3 months
Title
Incidence of hematopoietic stem cell reinfusion treatment Adverse Events [Safety and Tolerability])
Description
Incidence of hematopoietic stem cell reinfusion treatment Adverse Events [Safety and Tolerability])
Time Frame
1 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1)18-60 years old; 2)there are radiotherapy and chemotherapy indicators for cervical cancer;3)pathological diagnosis of squamous, adenocarcinoma or adenosquamous carcinoma;4)the Eastern Cooperative Oncology Group (ECOG) performance status score≤1; 5)the expected survival time was more than 3 months; 6)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;7)all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;8)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. Exclusion Criteria: 1) clinical diagnosis of bone marrow disease;2) imaging or pathological diagnosis of central nervous system or soft meningeal or bone or bone marrow metastases;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 radiochemotherapy contraindications;7)positive for human immunodeficiency virus (HIV);8)acute or chronic active hepatitis B or hepatitis C infection;9)History of gastrointestinal perforation and/or fistula, clinical signs or symptoms of intestinal obstruction and/or gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhoea), Crohn's disease, ulcerative colitis or chronic diarrhoea within the previous 6 months;10)evidence of an intra-abdominal pneumoperitoneum that cannot be explained by puncture or recent surgical intervention.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongling Zou, M.D.
Phone
13657690699
Email
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
Email
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
No
Citations:
PubMed Identifier
27764711
Citation
Bhargava A, Mishra DK, Jain SK, Srivastava RK, Lohiya NK, Mishra PK. Comparative assessment of lipid based nano-carrier systems for dendritic cell based targeting of tumor re-initiating cells in gynecological cancers. Mol Immunol. 2016 Nov;79:98-112. doi: 10.1016/j.molimm.2016.10.003. Epub 2016 Oct 17.
Results Reference
background
PubMed Identifier
35381675
Citation
Huang BH, Li J, Zou WY, Liu JR, Gu JL, Li XZ, Chen ML, Kuang LF. [Efficacy and safety of autologous hematopoietic stem cell transplantation in elderly multiple myeloma patients: a single center retrospective study]. Zhonghua Xue Ye Xue Za Zhi. 2022 Feb 14;43(2):141-145. doi: 10.3760/cma.j.issn.0253-2727.2022.02.009. Chinese.
Results Reference
background
PubMed Identifier
34512841
Citation
Fares S, Hadri H, Rachid M, Moutiqui T, Oukkache B, Quessar A. [Multiple myeloma and autologous haematopoietic stem-cell transplantation without cryopreservation: experiences of the Clinical Hematology Department of Casablanca, Morocco]. Pan Afr Med J. 2021 Jun 4;39:105. doi: 10.11604/pamj.2021.39.105.18994. eCollection 2021. French.
Results Reference
background
PubMed Identifier
34560187
Citation
Corbeau A, Kuipers SC, de Boer SM, Horeweg N, Hoogeman MS, Godart J, Nout RA. Correlations between bone marrow radiation dose and hematologic toxicity in locally advanced cervical cancer patients receiving chemoradiation with cisplatin: a systematic review. Radiother Oncol. 2021 Nov;164:128-137. doi: 10.1016/j.radonc.2021.09.009. Epub 2021 Sep 21.
Results Reference
background

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Hematopoietic Stem Cell-containing Autologous Blood Transfusion for Bone Marrow Protection in Patients With Cervical Cancer

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