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

NCT ID: NCT04460508

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-20
• Study Completion Date: 2023-03-20

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.

Conditions

Chemotherapy-induced Neutropenia; Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mecapegfilgrastim

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

Group Type: EXPERIMENTAL

Pegylated rhG-CSF

Intervention Type: DRUG

Pegylated rhG-CSF:6mg

rhG-CSF

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

Group Type: ACTIVE_COMPARATOR

rhG-CSF

Intervention Type: DRUG

rhG-CSF:5ug/kg/d

Interventions

Pegylated rhG-CSF

Pegylated rhG-CSF:6mg

Intervention Type: DRUG

rhG-CSF

rhG-CSF:5ug/kg/d

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 18 to 75 years;

2. Patients with primary malignant lymphoma confirmed by histopathology or immunomolecular biology and requiring treatment with multi-cycle high-intensity chemotherapy regimen;

3. ECOG performance status ≤ 1;

4. ANC ≥1.5×109/L, PLT≥80×109 /L, Hb≥ 75g/L, WBC ≥3.0×109/L;

5. Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment;

6. 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

1. Lymphoma central involvement;

2. Recipients of hematopoietic stem cell transplantation or organ transplantation;

3. Currently conducting clinical trials of other drugs;

4. There is an uncontrollable infection with body temperature ≥38℃;

5. 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

6. Patients with serious chronic diseases of heart, kidney, liver and other important organs;

7. Patients with severe uncontrolled diabetes;

8. Pregnant or lactating female patients.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Ou Bai, MD/PHD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ou BAI, doctor

Role: primary

oubai16@163.com

13039046656

Other Identifiers

mecapegfilgrastim-lym-2020-1

Identifier Type: -

Identifier Source: org_study_id