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
- Conditions
- Patients with Diffuse Large B-Cell LymphomaDLBCLCHOPR-
- Registration Number
- TCTR20170802002
- Lead Sponsor
- Apexcela Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated (Halted Prematurely)
- Sex
- All
- Target Recruitment
- 20
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of neutropenia/febrile neutropenia events during the first 2 chemotherapy cycles week 6 Collect rate of events from CRF,Safety of Leuco-Plus 300 in diffuse large B-cell lymphoma patients. week 6 Collect safety parameters, labs, adverse events from CRF
- Secondary Outcome Measures
Name Time Method Prophylactic effect of Leuco-Plus 300 on chemotherapy-induced neutropenia in DLBCL patients week 6 Time to achieve post-nadir ANC recovery to normal or near-normal levels from CRF,Outcomes of chemotherapy-induced neutropenia and febrile neutropenia week 6 Duration of neutropenia/FN, FN related mortality from CRF