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A Randomized Dose Finding Study of KRN125 (Pegfilgrastim) for the Treatment of Chemotherapy - Induced Neutropenia in Malignant Lymphoma


Phase 2
20 Years
74 Years
Not Enrolling
Both
Neutropenia

Thank you

Trial Information

A Randomized Dose Finding Study of KRN125 (Pegfilgrastim) for the Treatment of Chemotherapy - Induced Neutropenia in Malignant Lymphoma


Inclusion Criteria:



- patients diagnosed as malignant lymphoma

- patients who were refractory to anthracycline or anthraquinone containing
chemotherapy

- patients who are going to receive ESHAP or CHASE treatment regimen

- ECOG performance status =< 2

- patients who have appropriate bone marrow, hepatic and renal functions

- written informed consent

Exclusion Criteria:

- double cancer

- history of bone marrow transplantation or PBSCT

- more than 2 prior chemotherapy regimens

- primary hematologic disease such as myelodysplastic syndrome

- previous radiotherapy within 4 weeks of enrollment

- woman of childbearing potential who were either pregnant, breast feeding

- patients who participated in other clinical trials within the last 4 weeks of
enrollment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare the duration of severe neutropenia

Principal Investigator

Tomomitsu Hotta, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Nagoya Medical Center

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

KRN125/05-A04

NCT ID:

NCT00364468

Start Date:

March 2006

Completion Date:

Related Keywords:

  • Neutropenia
  • pegfilgrastim
  • neutropenia
  • cancer patients
  • lymphoma
  • Lymphoma
  • Neutropenia

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