Health Condition 1: D898- Other specified disorders involving the immune mechanism, not elsewhere classified
Conditions
Interventions
Intervention1: Tab Eltrombopag + Inj Filgrastim
With or without Inj Plerixafor: Tan Eltrombopag dose: 150mg once daily for 7 days
Inj Filgrastim dose: 5mcg per kg twice daily for 4 days
Control Interv
Sponsors
Christian Medical College Vellore
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 years old, and Diagnosis of Lymphoma with stable disease or disease in remission following chemotherapy and planned for ASCT.
Exclusion criteria
Exclusion criteria: Severe Hepatic Impairment (AST or ALT above 3 times ULN) Hypersensitivity to the drug or excipients Prior or active thrombosis Children
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the proportion of patients obtaining above 5 x 106/kg CD34+ cells on the first apheresis day.Timepoint: The primary efficacy endpoint is the proportion of patients obtaining above 5 x 106/kg CD34+ cells on the first apheresis day. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Compare the median number of days to neutrophil and platelet engraftment in both the groups (2) Compare the red blood cell and platelet transfusion requirement from the day of mobilization till engraftment (neutrophil or platelet engraftment, whichever occurs later) among the two groups (3) Compare the rates of infections and median hospital stay between the two groups (4) Compare the graft characteristics between the two groups (5) Compare the proportion of patients requiring Plerixafor use and a second day harvest.Timepoint: DAY 14 DAY 30 MONTH 2 TO MONTH 12 | — |
Countries
India
Contacts
Public ContactArchita R
Christian Medical College Vellore Ranipet campus
Outcome results
None listed