Study to evaluate the safety and efficacy of Pegfilgrastim in chemotherapy induced neutropenia
- Conditions
- Health Condition 1: D701- Agranulocytosis secondary to cancer chemotherapy
- Registration Number
- CTRI/2018/04/013221
- Lead Sponsor
- Virchow Biotech Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
1. Male or female patients aged between 18 â?? 65 years.
2. Patients with histologically confirmed tumors (breast
cancer, small cell lung cancer, Non-Hodgkinâ??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 >=1.5 x 109/L and plateletcount >= 100 x 109/L.
5. Patients with hemoglobin >=9 g/dl; WBC >=3,000/cu mm.
6. Patients with albumin >= 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. Patients who are willing to give the consent.
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, ymophoblastic 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of severe neutropenia (ANC 500 cells/µl)in cycle 1.Timepoint: 21 days
- Secondary Outcome Measures
Name Time Method Duration of severe neutropenia (ANC 500 cells/µl) in cycles 2&3. <br/ ><br> <br/ ><br>Incidence of febrile neutropenia (38o C and ANC � <br/ ><br>500 cells/µl) across all cycles. <br/ ><br> <br/ ><br>Number of days of use of antibiotics. <br/ ><br> <br/ ><br>Cumulative dose of filgrastim.Timepoint: Day 45 & Day 65