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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04460508
• Other study ID #: mecapegfilgrastim-lym-2020-1
• Status: Recruiting
• Phase: Phase 2
• Start date: December 20, 2020
• Est. completion date: March 20, 2023

Study information

• Verified date: July 2022
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: March 20, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Neutropenia
• Lymphoma
• Neutropenia

Intervention

Drug:
• Pegylated rhG-CSF
Pegylated rhG-CSF:6mg
• rhG-CSF
rhG-CSF:5ug/kg/d

Locations

Country	Name	City	State
China	The First Bethune Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of grade =3 neutropenia in cycle 1	Duration of subjects developing ANC lower than 1.0 × 109/L	21 days
Secondary	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	84 days
Secondary	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	84 days
Secondary	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	84 days