This phase 3 trial is comparing the effectiveness of ibrutinib (Imbruvica) plus chemotherapy versus chemotherapy alone in children and young adults with B-cell non-Hodgkin’s lymphoma (NHL). The main outcome to be measured will be survival without cancer returning, growing or spreading.
Ibrutinib is a targeted therapy for leukemia and lymphoma. This type of treatment only targets cancer cells and prevents them from growing. This leads to cancer cell death. Since targeted therapy attacks only cancer cells without damaging healthy ones, there are fewer side effects. Ibrutinib is approved for use in adult patients. The effectiveness of ibrutinib in younger patients (children and patients younger than age 30) remains under investigation.
This study is evaluating the effectiveness of ibrutinib with or without chemotherapy versus chemotherapy alone in children and young adults with B-cell NHL. The main outcome to be measured will be event-free survival (time from treatment until the cancer comes back, grows, or spreads).
Who are they looking for?
This study is recruiting 93 patients with B-cell NHL. Patients must have been diagnosed before age 18. Patients must not respond to conventional therapies or have relapsed. Female patients should not be pregnant.
Patients with bleeding disorders, heart problems, HIV, or hepatitis cannot participate. Female patients who are pregnant or breast feeding cannot participate. Patients who were treated with ibrutinib before cannot participate. Patients who will have a stem cell transplant within 6 months cannot participate.
How will it work
This study will have two parts: Part 1 and Part 2. In Part 1, the metabolism of ibrutinib by the body will be measured. All patients will be given ibrutinib only. Patients in Part 1 will be younger than age 18. Part 2 of the study will evaluate the effectiveness of ibrutinib with or without chemotherapy. Patients in Part 2 will be age 30 or younger. Patients will receive 3 cycles of RICE (rituximab, ifosfamide, carboplatin, etoposide) or RVICI (rituximab, vincristine, ifosfamide, carboplatin, and idarubicin) chemotherapy. Patients will be followed-up for approximately 4.2 years.
The main outcome to be measured will be event-free survival at follow-up. The number of patients who have either a complete disappearance of cancer or tumor shrinkage after treatment will also be measured. The number of patients still alive 2 to 3 years after treatment will also be measured. Safety will be evaluated from the number of patients who have side effects from treatment.