Health Condition 1: D701- Agranulocytosis secondary to cancer chemotherapy
Conditions
Interventions
Intervention1: Neupogen: Granulocyte colony stimulating factor
Control Intervention1: Neupogen: Granulocyte colony stimulating factor
Sponsors
Virchow Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 18 ââ?¬â?? 65 years. 2. Patients with histologically confirmed tumors (breast cancer, small cell lung cancer, Non-Hodgkinââ?¬•s Lymphoma). 3. Patients who are planned to receive myelosupresive chemotherapy regimen (which is known to induce severe neutropenia). 4. Patients with baseline ANC of ââ?°Â¥1.5 x 10 9/ L and platelet count ââ?°Â¥ 100 x 10 9/ L. 5. Patients with hemoglobin ââ?°Â¥9 g/dl; WBC ââ?°Â¥3,000/cu mm. 6. Patients with albumin ââ?°Â¥ 3.0 g/dl. 7. Performance status as per ECOG (Eastern Cooperative Group) score 0, 1 or 2. 8. Patients with life expectancy more than 2 months. 9. Patients scheduled to undergo chemotherapy at least for 3 cycles. 10. Patients who are available for 15 days during each post chemotherapy cycle. 11. Administer Neutrogen to Group 1 and Neupogen to Group 2 containing G-CSF 5 Ã?µg/kg/day subcutaneously daily once 24 - 30hrs after chemotherapy for 14 days or continue the same until ANC level >10,000 cells/Ã?µl after the expected nadir for 2 days
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women or patients planning to become pregnant. 2. Known allergic reactions to study medications. 3. Patients with myelodysplastic syndrome, acute lymphoblastic or myeloblastic leukemia, lymophoblastic lymphoma, myeloma or severe pneumonia, hypotension, multi-organ dysfunction. 4. Patients with prior exposure to G-CSF or GM-CSF or to its pegylated products. 5. Myelotoxic concomitant treatment such as chloramphenicol, sulphmethoxarate, immunomodulating agents, interferons during 10 days before randomization. 6. Central nervous system metastases. 7. Patients who had an immediate/ concurrent exposure to radio therapy and surgery. 8. Abnormal cardiovascular, hepatic and renal laboratory parameters that are deemed to be clinically significant as per investigator. 9. Known cases of sickle cell anemia. 10. History of AIDS, or HIV positive, active hepatitis and active tuberculosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of severe neutropenia (ANC 500 cells/Ã?µl) in cycle 1.Timepoint: Duration of severe neutropenia (ANC 500 cells/Ã?µl) in cycle 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of severe neutropenia (ANC 500 cells/Ã?µl) in cycles 2&3. Incidence of febrile neutropenia (38 o C and ANC ââ?°Â¤ 500 cells/Ã?µl) across all cycles. Number of days of use of antibiotics. Cumulative dose of filgrastim.Timepoint: Day 45 & Day 65 | — |
Countries
India
Contacts
Public ContactDr Hemanth Nandigala
Virchow Biotech Private Limited
Outcome results
None listed