What happens if I decide to participate?
- Prior to undergoing any medical procedures to determine if you may participate in the study, you will review the informed consent form with the study staff and be asked to sign it, if you are still interested in participating. The informed consent form is meant to help you understand everything that will happen if you participate in the study, including the possible risks and benefits associated with your participation. You will receive study-related medical care and study medication at no cost.
- Your chemotherapy treatment will consist of 6 cycles. Each cycle will last 21 days and, you will receive Rituximab Biosimilar or Reference Rituximab followed by CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone). All these drugs except the prednisone (which is taken as a pill by mouth), are given as a drip (infusion) into a vein.
- You will be expected to visit the study center weekly during treatment period – day 1, 8 and 15 of each cycle for consultation appointment with your study doctor, follow-by trial treatment and procedures. Your travel to your study visits will be reimbursed once you are enrolled into the study.
- On 21-30 days after receiving the 6th dose of Rituximab Biosimilar or Reference Ritiuximab (cycle 6) you will be asked to return to the study center to follow up on the state of your disease and have more examinations.
- 3 follow-up visits will be done at 3 months, 6 months and 9 months after the last dose of chemotherapy.
- During the study visits, the study staff will discuss your current condition with you. In addition, blood and urine samples will be collected from you for laboratory testing. Between visits, you will be asked to take the study drug as required.
- During the study, you can call your study staff at any time, to report problems or ask questions.
- You are required to return for unscheduled visits should your condition need immediate medical attention.
- Your participation is voluntary. You can change your mind and stop study medication at any time. Your study doctor can also stop study medication and remove you from the study at anytime (if it is in your best interest).