NCT04460508

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

December 20, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

June 28, 2020

Last Update Submit

July 6, 2022

Conditions

Chemotherapy-induced NeutropeniaLymphoma

Outcome Measures

Primary Outcomes (1)

  • Duration of grade ≥3 neutropenia in cycle 1

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

    21 days

Secondary Outcomes (3)

  • Incidence of grade ≥3 neutropenia in cycle 1-4

    84 days

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

    84 days

  • Incidence of adverse events (AEs)

    84 days

Study Arms (2)

Mecapegfilgrastim

EXPERIMENTAL

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

Drug: Pegylated rhG-CSF

rhG-CSF

ACTIVE COMPARATOR

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

Drug: rhG-CSF

Interventions

Pegylated rhG-CSFDRUG

Pegylated rhG-CSF:6mg

Mecapegfilgrastim
rhG-CSFDRUG

rhG-CSF:5ug/kg/d

rhG-CSF

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 28, 2020

First Posted

July 7, 2020

Study Start

December 20, 2020

Primary Completion

December 20, 2022

Study Completion

March 20, 2023

Last Updated

July 7, 2022

Record last verified: 2022-07

Locations

CN(1)