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Clinical Trials/TCTR20170802002
TCTR20170802002
Terminated
Phase 4

A Prospective Study on Efficacy and Safety of Filgrastim (Leuco-Plus 300) for Prevention of Chemotherapy Induced Neutropenia in Patients with Diffuse Large B-Cell Lymphoma

Apexcela Co., Ltd.0 sites20 target enrollmentAugust 2, 2017
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ConditionsPatients with Diffuse Large B&#45Cell LymphomaDLBCLCHOPR&#45

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Patients with Diffuse Large B&#45
Sponsor
Apexcela Co., Ltd.
Enrollment
20
Status
Terminated
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 2, 2017
End Date
April 30, 2019
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Apexcela Co., Ltd.

Eligibility Criteria

Inclusion Criteria

  • •1\. Male or female subjects, aged ≥ 18 years old at time of obtained consent, diagnosed with diffuse large B\-cell lymphoma (DLBCL).
  • •2\. Have appropriate plan by physicians to start 1stline chemotherapy regimen of CHOP alone or R\-CHOP together with Leuco\-Plus 300 for primary prophylaxis of chemotherapy\-induced neutropenia. Secondary prophylaxis with Leuco\-Plus 300 will be excluded.
  • •3\. ECOG performance status 0\-2
  • •4\. Patients who have consented to participate in the study in writing prior to any study procedures.
  • •5\. Willing and able to comply with scheduled visits and laboratory tests.

Exclusion Criteria

  • •1\. Subjects with current grade 3 or 4 neutropenia (as per CTCAE version 4\.03\) and undergoing treatment with filgrastim at screening.
  • •2\. Patients who have previously treated with filgrastim within 4 weeks prior to screening visit.
  • •3\. Patients who experienced febrile neutropenia at least 1 episode prior to screening.
  • •4\. Diagnosed with Chronic myeloid leukemia or Myelodysplastic syndrome or other Lymphoma than DLBCL.
  • •5\. Hypersensitivity to Leuco\-Plus 300 or to any other filgrastim.
  • •6\. Hypersensitivity to Escherichia coli\-derived proteins
  • •7\. Prior bone marrow or stem cell transplant.
  • •8\. Patients who are pregnant or breastfeeding.
  • •9\. Women of childbearing potential who are not willing to use an effective method of birth control.

Outcomes

Primary Outcomes

Not specified

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