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Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies

Primary Purpose

Gynecologic Malignant Tumor

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Mecapegfilgrastim Injection

About this trial

This is an interventional treatment trial for Gynecologic Malignant Tumor focused on measuring neutropenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ages 18-70
Weight ≥45 kg
≤2 lines chemotherapy or postoperative adjuvant chemotherapy patients with cervical cancer, ovarian cancer and endometrial cancer
Receive paclitaxel combined with platinum three weeks per cycle of chemotherapy
With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
Expected survival time of > 3 months
Main organ functions meet the following criteria:
1. Hb≥75g/L; WBC≥3.0×109/L; ANC≥1.5×109/L; PLT≥80×109/L;
2. APTT-ULN≤10s; PT-ULN≤3s; TT-ULN≤3s;
3. ALT≤2.5×ULN; AST≤2.5×ULN; TBIL≤2.5×ULN;
4. BUN≤1.5×ULN; Cr≤1.5×ULN; UA≤1.5×ULN；Creatinine clearance≥40mL/min;
5. without obvious cardiac dysfunction
Provided consent for participation

Exclusion Criteria:

With uncontrollable infections or receive systemic antibiotics within 72 hours prior to chemotherapy
Pregnant or lactating women
Received bone marrow or hematopoietic stem cell transplantation within the past 3 months
Concurrent chemoradiotherapy
Presence of hematological disorders: systemic lupus erythematosus, sjogren's syndrome, rheumatic autoimmune disease, mixed and hoof tissue disease, autoimmune hemolytic anemia, leukopenia , chronic granulocyte leukemia, bone marrow dysplasia syndrome, aplastic anemia, congenital and idiopathic neutropenia, myelodysplastic syndrome, cyclic neutropenia, primary and secondary thrombocytopenic purpura, etc
Presence of risk of thrombus or high risk of clotting
Presence of psychosis, neurological disease or brain metastases from tumors
Presence of uncontrollable complicated disease including symptomatic congestive heart failure, uncontrollable hypertension, unstable angina pectoris, active peptic ulcer, or hemorrhagic disease
Presence of uncontrollable infectious diseases, active viral hepatitis, tuberculosis, HIV
Allergic to recombinant human granulocyte stimulating factor or other biological products of E. coli origin
Received clinical trials within 1 month prior to enrollment

Sites / Locations

No. 270, Dongan Road, Xuhui District, Shanghai, China

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PEG-rhG-CSF prevention

non-prevention

Arm Description

Mecapegfilgrastim subcutaneous injection, 6mg, 24-48h after the end of antitumor drug administration in each chemotherapy cycle,

Only close monitoring after chemotherapy

Outcomes

Primary Outcome Measures

Incidence of third/fourth level neutropenia

Incidence of third/fourth level neutropenia during three cycles chemotherapy

Secondary Outcome Measures

Incidence of febrile neutropenia

Incidence of febrile neutropenia during every cycle chemotherapy

The duration time of third/fourth level neutropenia

The duration time of third/fourth level neutropenia during three cycles chemotherapy

Incidence of infection

Incidence of third/fourth level neutropenia during three cycles chemotherapy

delay time of chemotherapy

The delay time of the next cycle of chemotherapy due to FN or infection

RDI of chemotherapy

Relative dose intensity of the second and third chemotherapy

Adverse events

Incidence of adverse events related to granulocyte colony stimulating factor according to common Terminology Criteria for Adverse Events (CTCAE) v5.0

Full Information

NCT ID

NCT04773327

First Posted

February 2, 2021

Last Updated

February 24, 2021

Sponsor

Xiaohua Wu MD

1. Study Identification

Unique Protocol Identification Number

NCT04773327

Brief Title

Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies

Official Title

A Multicenter, Randomized Controlled, Open Clinical Study of the Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemotherapy in Patients With Gynecological Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 2021 (Anticipated)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xiaohua Wu MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This study is a multi-center, forward-looking, open, randomized, controlled clinical trial. This study aims to analyze the effects of Mecapegfilgrastim Injection prevention versus non-prevention for neutropenia in ovarian cancer, cervical cancer, endometrial cancer patients after chemical therapy. Patients are randomized into study group and control group. All patients receive PTX+platinum chemotherapy of 3 weeks. In study group, patients accept PEG-rhG-CSF 24-48 hours from the chemotherapy. While the control group patients are only observed closely. Patient receive three courses of treatment. The primary end is the incidence of 3/4 level neutropenia in three courses of chemotherapy. The secondary ends include: the incidences and duration of neutropenia in every course of chemotherapy, the incidences of FN in three courses and every course of chemotherapy, the incidences of infection in three courses and every course of chemotherapy, the delay time of the next cycle of chemotherapy due to FN or infection, the RDI of the second and third cycles of chemotherapy, adverse events related to G-CSF, quality of life, cost of medicine and admitting.

6. Conditions and Keywords

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

Gynecologic Malignant Tumor

Keywords

neutropenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PEG-rhG-CSF prevention

Arm Type

Experimental

Arm Description

Mecapegfilgrastim subcutaneous injection, 6mg, 24-48h after the end of antitumor drug administration in each chemotherapy cycle,

Arm Title

non-prevention

Arm Type

No Intervention

Arm Description

Only close monitoring after chemotherapy

Intervention Type

Other

Intervention Name(s)

Mecapegfilgrastim Injection

Other Intervention Name(s)

PEG- rhg - csf

Intervention Description

24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle

Primary Outcome Measure Information:

Title

Incidence of third/fourth level neutropenia

Description

Incidence of third/fourth level neutropenia during three cycles chemotherapy

Time Frame

three months

Secondary Outcome Measure Information:

Title

Incidence of febrile neutropenia

Description

Incidence of febrile neutropenia during every cycle chemotherapy

Time Frame

three months

Title

The duration time of third/fourth level neutropenia

Description

The duration time of third/fourth level neutropenia during three cycles chemotherapy

Time Frame

three months

Title

Incidence of infection

Description

Incidence of third/fourth level neutropenia during three cycles chemotherapy

Time Frame

three months

Title

delay time of chemotherapy

Description

The delay time of the next cycle of chemotherapy due to FN or infection

Time Frame

three months

Title

RDI of chemotherapy

Description

Relative dose intensity of the second and third chemotherapy

Time Frame

three months

Title

Adverse events

Description

Incidence of adverse events related to granulocyte colony stimulating factor according to common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time Frame

three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ages 18-70 Weight ≥45 kg ≤2 lines chemotherapy or postoperative adjuvant chemotherapy patients with cervical cancer, ovarian cancer and endometrial cancer Receive paclitaxel combined with platinum three weeks per cycle of chemotherapy With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 Expected survival time of > 3 months Main organ functions meet the following criteria: Hb≥75g/L; WBC≥3.0×109/L; ANC≥1.5×109/L; PLT≥80×109/L; APTT-ULN≤10s; PT-ULN≤3s; TT-ULN≤3s; ALT≤2.5×ULN; AST≤2.5×ULN; TBIL≤2.5×ULN; BUN≤1.5×ULN; Cr≤1.5×ULN; UA≤1.5×ULN；Creatinine clearance≥40mL/min; without obvious cardiac dysfunction Provided consent for participation Exclusion Criteria: With uncontrollable infections or receive systemic antibiotics within 72 hours prior to chemotherapy Pregnant or lactating women Received bone marrow or hematopoietic stem cell transplantation within the past 3 months Concurrent chemoradiotherapy Presence of hematological disorders: systemic lupus erythematosus, sjogren's syndrome, rheumatic autoimmune disease, mixed and hoof tissue disease, autoimmune hemolytic anemia, leukopenia , chronic granulocyte leukemia, bone marrow dysplasia syndrome, aplastic anemia, congenital and idiopathic neutropenia, myelodysplastic syndrome, cyclic neutropenia, primary and secondary thrombocytopenic purpura, etc Presence of risk of thrombus or high risk of clotting Presence of psychosis, neurological disease or brain metastases from tumors Presence of uncontrollable complicated disease including symptomatic congestive heart failure, uncontrollable hypertension, unstable angina pectoris, active peptic ulcer, or hemorrhagic disease Presence of uncontrollable infectious diseases, active viral hepatitis, tuberculosis, HIV Allergic to recombinant human granulocyte stimulating factor or other biological products of E. coli origin Received clinical trials within 1 month prior to enrollment

Central Contact Person:

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

Lingfang Xia, M.D.

Phone

13774211977

nightxlf@163.com

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

Xiaohua Wu, MD&PHD

Phone

+862164175590

alizheng@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaohua Wu, MD&PHD

Organizational Affiliation

director of gynecologic oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

No. 270, Dongan Road, Xuhui District, Shanghai, China

City

Shanghai

State/Province

Shanghai

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaohua Wu

Phone

+862164175590

alizheng@126.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

data is available per require after approved by ethics broad

Learn more about this trial

Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies

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