Patients with Diffuse Large B-
Conditions
Interventions
granulocyte-
colony stimulating factor,
G-
Experimental Biological/Vaccine
Leuco-
Plus 300 (Filgrastim 300 mcg)
Sponsors
Apexcela Co., Ltd.
Siam Bioscience Co.,
Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactPreechanoot Aimruen
Siam Bioscience Co., Ltd.
Outcome results
None listed