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A phase III, clinical study of KRN125

A clinical study of KRN125 compared to KRN8601 for chemotherapy-induced neutropenia in elderly patients with non-Hodgkin's lymphoma

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221502
Enrollment
Unknown
Registered
2011-06-30
Start date
2011-06-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced neutropenia

Interventions

investigational material(s) Generic name etc : KRN125 INN of investigational material : pegfilgrastim Therapeutic category code : 339 Other agents relating to blood and body fluides Dosage and Adminis

Sponsors

Kyowa Hakko Kirin Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Written informed consent - Diagnosed with non-Hodgkin's lymphoma - Going to receive (R) CHOP treatment regimen - No prior chemotherapy - ECOG PS =< 2 - Appropriate bone marrow, hepatic, renal and heart functions

Exclusion criteria

Exclusion criteria: - Complication or anamnesis of cardiac disease, such as heart failure and severe arrhythmia - Double cancer - Previous bone marrow or peripheral blood stem cell transplantation - Primary hematologic disease such as myelodysplastic syndrome or aplastic anemia - Undergoing interstitial pneumonia treatment - Previous radiotherapy within 4 weeks of enrollment

Design outcomes

Primary

MeasureTime frame
Efficacy: duration of severe neutropenia—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026