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Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma

Primary Purpose

Chemotherapy-induced Neutropenia, Lymphoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Pegylated rhG-CSF

rhG-CSF

About this trial

This is an interventional prevention trial for Chemotherapy-induced Neutropenia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 to 75 years;
Patients with primary malignant lymphoma confirmed by histopathology or immunomolecular biology and requiring treatment with multi-cycle high-intensity chemotherapy regimen;
ECOG performance status ≤ 1;
ANC ≥1.5×109/L, PLT≥80×109 /L, Hb≥ 75g/L, WBC ≥3.0×109/L;
Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment;
Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedul.

Exclusion Criteria:

Lymphoma central involvement;
Recipients of hematopoietic stem cell transplantation or organ transplantation;
Currently conducting clinical trials of other drugs;
There is an uncontrollable infection with body temperature ≥38℃;
liver function examination: total bilirubin (TBIL., alanine aminotransferase (ALT. and ascetic aminotransferase (AST. were all 2.5 times the upper limit of the normal value of >; if they were caused by liver metastasis, the upper limit of the normal value of > was 5 times;Renal function test: serum creatinine (Cr. >2 times the upper limit of normal value
Patients with serious chronic diseases of heart, kidney, liver and other important organs;
Patients with severe uncontrolled diabetes;
Pregnant or lactating female patients.

Sites / Locations

The First Bethune Hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mecapegfilgrastim

rhG-CSF

Arm Description

Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle.

Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle.

Outcomes

Primary Outcome Measures

Duration of grade ≥3 neutropenia in cycle 1

Duration of subjects developing ANC lower than 1.0 × 109/L

Secondary Outcome Measures

Incidence of grade ≥3 neutropenia in cycle 1-4

Proportion of subjects developing ANC lower than 1.0 × 109/L from cycle 1 to cycle 4

Incidenc of febrile neutropenia (FN) in cycle 1-4

Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius from cycle 1 to cycle 4

Incidence of adverse events (AEs)

Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0

Full Information

NCT ID

NCT04460508

First Posted

June 28, 2020

Last Updated

July 6, 2022

Sponsor

The First Hospital of Jilin University

1. Study Identification

Unique Protocol Identification Number

NCT04460508

Brief Title

Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma

Official Title

Efficacy and Safety of Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma: a Randomized, Open-label, Active-controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 20, 2020 (Actual)

Primary Completion Date

December 20, 2022 (Anticipated)

Study Completion Date

March 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Hospital of Jilin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy.A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with ﬁlgrastim. This study is to evaluate efficacy and safety in chemotherapy-induced neutropenia of once-per-cycle Mecapegfilgrastim Injection(PEG-G-CSF) and daily G-CSF in Patients with lymphoma patients.

Detailed Description

This is a randomized, controlled study. A total of 170 lymphoma patients who are eligible are planned to randomized assigned into two groups to receive mecapegfilgrastim fixed dose of 6 mg or filgrastim 5 µg/kg/day during chemotherapy. The primary endpoint is the duration of grade ≥3 neutropenia in cycle 1. The secondary endpoints include incidence of grade ≥3 neutropenia and febrile neutropenia (FN) in cycle 1-4, The pharmacoeconomics and safety profile are also evaluated.

6. Conditions and Keywords

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

Chemotherapy-induced Neutropenia, Lymphoma

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mecapegfilgrastim

Arm Type

Experimental

Arm Description

Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle.

Arm Title

rhG-CSF

Arm Type

Active Comparator

Arm Description

Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle.

Intervention Type

Drug

Intervention Name(s)

Pegylated rhG-CSF

Intervention Description

Pegylated rhG-CSF:6mg

Intervention Type

Drug

Intervention Name(s)

rhG-CSF

Intervention Description

rhG-CSF:5ug/kg/d

Primary Outcome Measure Information:

Title

Duration of grade ≥3 neutropenia in cycle 1

Description

Duration of subjects developing ANC lower than 1.0 × 109/L

Time Frame

21 days

Secondary Outcome Measure Information:

Title

Incidence of grade ≥3 neutropenia in cycle 1-4

Description

Proportion of subjects developing ANC lower than 1.0 × 109/L from cycle 1 to cycle 4

Time Frame

84 days

Title

Incidenc of febrile neutropenia (FN) in cycle 1-4

Description

Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius from cycle 1 to cycle 4

Time Frame

84 days

Title

Incidence of adverse events (AEs)

Description

Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0

Time Frame

84 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 to 75 years; Patients with primary malignant lymphoma confirmed by histopathology or immunomolecular biology and requiring treatment with multi-cycle high-intensity chemotherapy regimen; ECOG performance status ≤ 1; ANC ≥1.5×109/L, PLT≥80×109 /L, Hb≥ 75g/L, WBC ≥3.0×109/L; Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment; Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedul. Exclusion Criteria: Lymphoma central involvement; Recipients of hematopoietic stem cell transplantation or organ transplantation; Currently conducting clinical trials of other drugs; There is an uncontrollable infection with body temperature ≥38℃; liver function examination: total bilirubin (TBIL., alanine aminotransferase (ALT. and ascetic aminotransferase (AST. were all 2.5 times the upper limit of the normal value of >; if they were caused by liver metastasis, the upper limit of the normal value of > was 5 times;Renal function test: serum creatinine (Cr. >2 times the upper limit of normal value Patients with serious chronic diseases of heart, kidney, liver and other important organs; Patients with severe uncontrolled diabetes; Pregnant or lactating female patients.

Facility Information:

Facility Name

The First Bethune Hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ou BAI, doctor

Phone

13039046656

oubai16@163.com

12. IPD Sharing Statement

Learn more about this trial

Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma

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