Health Condition 1: C819- Hodgkin lymphoma, unspecified Health Condition 2: C499- Malignant neoplasm of connective and soft tissue, unspecified Health Condition 3: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis Health Condition 4: C858- Other specified types of non-Hodgkin lymphoma
Conditions
Interventions
Intervention1: Pegfilgrastim: Long acting granulocyte stimulating factor administered as a single dose
Control Intervention1: Conventional filgrastim: Administer as daily 100 microgram/kg injections t
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Age 1. Receiving dose-intensive chemotherapy (expected incidence of FN without growth factor >20%) and qualifying for standard indication of growth factor support. 2. Receiving growth-factor in view of interval-compression of chemotherapy showing significant benefit in terms of patient outcome 3. Receiving growth-factor as a part of standard chemotherapy protocol
Exclusion criteria
Exclusion criteria: 1. Prior radiation therapy within 4 weeks of randomization 2. Marrow involvement by tumor 3. Prior bone marrow or stem-cell transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether single dose of long acting pegylated filgrastim is superior to conventional filgrastim in terms of incidence of febrile neutropeniaTimepoint: 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare between the two groups: 1. Duration of neutrophil recovery 2. Depth of absolute neutrophil count nadir 3. Chemotherapy cycle duration 4. Incidence of mucositis 5. Number of transfusions 6. Incidence of grade 3 or higher adverse event to drug 7. Magnitude of CD34 stem cell mobilization Timepoint: 2 weeks | — |
Countries
India
Contacts
Public ContactDr Jagdish Prasad Meena
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed