NCT06665737

Brief Summary

The goal of this clinical trial is to Primary Objectives:

  1. 1.To compare the incidence of febrile neutropenia in patients with non-Hodgkin's lymphoma who received early or late granulocyte colony-stimulating factor (G-CSF) during standard chemotherapy in a multicenter study
  2. 2.To determine the incidence of leukopenia and neutropenia in patients with non-Hodgkin's lymphoma who received early or late G-CSF during standard chemotherapy in a multicenter study
  3. 3.To determine changes in white blood cell, hemoglobin, and platelet levels in patients with non-Hodgkin's lymphoma who received early or late G-CSF during standard chemotherapy.
  4. 4.To determine the quality of life of patients with non-Hodgkin's lymphoma who undergoing standard chemotherapy and with neutropenia Researchers will compare the outcome between patients received either early G-CSF (within 72 hours) or late G-CSF (after 72 hours).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for phase_4

Timeline
8mo left

Started Feb 2025

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Feb 2025Dec 2026

First Submitted

Initial submission to the registry

October 29, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 28, 2025

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

October 29, 2024

Last Update Submit

January 24, 2025

Conditions

Non-Hodgkin's Lymphoma (NHL)Granulocyte Colony Stimulating FactorFebrile Neutropenia (FN)Myelosuppression Adult

Keywords

Non-Hodgkin's lymphomaFebrile neutropeniaGranulocyte Colony Stimulating FactorMyelosuppression

Outcome Measures

Primary Outcomes (2)

  • Incidence of febrile neutropenia

    Incidence of febrile neutropenia in each course

    One year

  • Incidence of leukopenia and neutropenia

    Incidence of leukopenia and neutropenia in each course

    One year

Secondary Outcomes (3)

  • Incidence of grade 3 or 4 of myelosuppression

    One year

  • Time of visits to outpatient (OPD) and emergency clinics (ER)

    One year

  • Quality of life (QoL) after chemotherapy

    One year

Study Arms (2)

Early receiving G-CSF group

ACTIVE COMPARATOR

Early receiving G-CSF group Patients in early receiving G-CSF group accept within 72 hours post chemotherapy

Drug: Early receiving G-CSF group

Late receiving G-CSF group

PLACEBO COMPARATOR

Last receiving G-CSF group Patients in early receiving G-CSF group accept after 72 hours post chemotherapy

Drug: Late receiving G-CSF group

Interventions

Early receiving G-CSF groupDRUG

Early receiving G-CSF group will be given within 72 hours post chemotherapy

Early receiving G-CSF group
Late receiving G-CSF groupDRUG

Late receiving G-CSF group will be given after 72 hours post chemotherapy

Late receiving G-CSF group

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years or old
  • Confirmed lymphoma undergoing standard chemotherapy
  • Signed an approval informed consent
  • Has a good understanding of Thai
  • Available for follow-up after chemotherapy

You may not qualify if:

  • Pregnancy or lactation
  • Serious concomitant diseases and discontinuous treatment such as cardiovascular, liver, or kidney diseases
  • Contraindication to chemotherapy or G-CSF administration
  • Antibiotic use within 1 week prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University

Bangkok, Bangkok, 10400, Thailand

Location

Rajavithi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

Internal Medicine Unit, Pranongklao Hospital

Nontaburi, Nontaburi, 11000, Thailand

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinFebrile Neutropenia

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeutropeniaAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesLeukocyte Disorders

Central Study Contacts

Praviwan Thungthong PT Rajavithi Hospital, M.D.

CONTACT

+662-206-2900pthungthong@gmail.com

Supat Chamnanchanunt SC Department of Clinical Tropical Medicine, Mahidol University, M.D.

CONTACT

+662-354-9100supat.cha@mahidol.ac.th

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Group A: Early receiving G-CSF Group B: Late receiving G-CSF
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2024

First Posted

October 30, 2024

Study Start

February 1, 2025

Primary Completion

February 27, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 28, 2025

Record last verified: 2024-10

Locations

TH(3)