Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Yonsei University
1. Subjects who meet the inclusion/exclusion criteria for this study will be randomized to two arms, Arm A and Arm B, alternating between patients receiving prophylactic Neulapeg and patients not receiving prophylactic Neulapeg. Once assigned, they will be followed until the end of the 8th cycle of modified FOLFIRINOX. 2. Patients assigned to the arm receiving prophylactic Neulapeg will receive Neulapeg subcutaneously 24 hours after the end of modified FOLFIRINOX dosing. (This should be administered no later than 72 hours, and Neulapeg will only be given for a maximum of 8 cycles.) 3. Patients in both arms will have additional visits at the discretion of the investigator for hematologic toxicity surveillance on days 7-10 of modified FOLFIRINOX dosing during the first 4 cycles. Thereafter, patients will be seen only at the time of chemotherapy administration at the discretion of the investigator. 4. Patients in both arms will be instructed to return for any fever greater than 38.3 degrees Celsius or greater than 38.0 degrees Celsius lasting more than 1 hour. 5. Patients assigned to the arm not receiving prophylactic Neulapeg will not receive intervention with G-CSF for neutropenia of grade 2 or less. 6. Patients assigned to the no prophylactic Neulapeg arm will be crossover to prophylactic Neulapeg if they develop Grade 3-4 neutropenia or neutropenic fever. Crossover subjects will receive up to 8 cycles of prophylactic Neulapeg as a secondary treatment regardless of starting cycle. 7. Hematologic toxicity monitored every cycle for 8 cycles / Quality of life assessed according to EORTC QLQ-C30 at baseline, once every 2 weeks for a total of 5 times (Baseline, Cycle 2 Day 1, Cycle 4 Day1 , Cycle 6 Day 1 , Cycle 8 Day 1) / completion of the bone pain questionnaire at baseline, once every 1 cycle for the first 4 cycles, and then every 2 cycles for a total of 7 times (Baseline, Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 6 Day 1, Cycle 8 Day 1). The mFOLFIRINOX will be administered every 2 weeks for up to 8 cycles, while Neulapeg will be administered within 24-72 hours of the end of dosing and will be available for up to 8 cycles only. The crossover control arm will continue as usual. 8. The modified FOLFIRINOX chemotherapy regimen will be administered at the original dose at the start of Cycle 1, with subsequent dose deferral until recovery of a neutrophil count ≥1,000 /mm3 in the event of toxicity, with dose reduction at the discretion of the investigator.
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
