Health Condition 1: null- Chemotherapy induced neutropenia in children.
Conditions
Interventions
If absolute Neutrophil count (ANC) post-nadir >
Intervention1: Low-dose Filgrastim: &
#61600
Start on 2.5 mcg/kg/day, starting from 2nd day of the end of chemo cycle (NOT to be given within 24 hrs of chemo), daily till post ANC>
5000/cmm on 2 occasions.
&
EOS at end of one chemotherapy cycle.
&
CBC and platelet count to be obtained before starting treatment and monitored daily.
&
5 x 109 /L then further study treatment to be discontinued for that particular cycle (due to potential complications of leukocytosis)
Control Intervention1: Standard ?dose Filgrastim: &
Start on 5 mcg/kg/day, starting from 2nd day of the chemo cycle (NOT to be given within 24 hrs of chemo), daily till post ANC>
Sponsors
Terry Fox Foundation
Eligibility
Inclusion criteria
Inclusion criteria: &#61600; Newly diagnosed pediatric (age < 18 yrs) patients with acute lymphoblastic leukemia in first complete remission after induction and planned for consolidation chemotherapy or patients with rhabdomyosarcoma (RMS)/Ewing?s sarcoma (ES) and osteogenic sarcoma (OGS) planned for first cycle of chemotherapy. &#61600; ECOG performance status < 2 (Karnofsky >=60%). &#61600; Life expectancy of greater than 6 months. &#61600; Patients must have normal organ and marrow function as defined below - Leukocytes > 3,000/mcL - absolute Neutrophil count > 1,500/mcL - platelets > 100,000/mcL - total bilirubin - within normal institutional limits - AST (SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal. - creatinine - within normal institutional Limits - creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. &#61600; Bone marrow in remission (< 5% blasts in marrow) in ALL or not involved at baseline in RMS and OGS &#61600; Ability of patients to understand and the willingness to sign a written informed consent.
Exclusion criteria
Exclusion criteria: &#61600; Patients who have had GCSF prior to entering the study or those who have not recovered from adverse events due to agents administered earlier. &#61600; Patients may not be receiving /received any other investigational agents within past 4 weeks. &#61600; Any planned radiotherapy during the study period. &#61600; History of allergic reactions attributed to compounds of similar chemical or biologic composition to G-CSF. &#61600; Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements. &#61600; Prior systemic anti-infective treatment within 72 hours of chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the duration of grade IV neutropenia between the two arms.Timepoint: 2 years (At the end of study) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoints would include comparative incidence of grade IV neutropenia, depth of Neutrophil nadir (mean + sd), total number of antibiotic and hospital days, total number of days of G-CSF total dose of G-CSF and relative safety as measured by reports of adverse events and changes in laboratory values between two arms. Timepoint: 2 years (At the end of study) | — |
Countries
India
Contacts
Public ContactDr. Brijesh Arora
Assistant Proffessor, Medical Oncology
Outcome results
None listed