This is a multicentre, open-label, phase II study of ibrutinib 560 mg in combination with R-ICE for treatment of transplant-eligible relapsed/refractory diffuse large B-cell lymphoma.
All patients will receive R-ICE therapy for 2 cycles followed by PET-CT assessment (PET-2). Ibrutinib 560 mg will be added to the RICE regimen based on results of PET-2 as follows: * Patients in CR will continue with 2 more cycles of R-ICE and proceed onto ASCT. These patients will not receive ibrutinib. * In patients with stable disease or achieving a response that is less than CR, ibrutinib 560 mg will be added. The combination of ibrutinib-RICE will be given for 2 cycles and will be followed by PET-CT assessment (PET-4). Patients who achieve ≥ PR at this point will proceed onto ASCT. * Patients who have disease progression will be removed from the trial. Hematopoietic stem cell harvesting can be performed following count recovery at any cycle of R-ICE, but preferably cycle 2. Transplant conditioning regimen will be with standard BEAM chemotherapy (carmustine, etoposide, cytarabine, melphalan). Following ASCT, ibrutinib will be given as maintenance therapy for patients who did not achieve a CR at the time of PET-2 assessment. This will be continued for up to 1 year after ASCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Ibrutinib will be added to RICE regimen for patients not achieving a complete remission at interim PET-2. Ibrutinib will be continued for up to 1 year after autologous transplantation.
National University Hospital Singapore
Singapore, Singapore
NOT_YET_RECRUITINGSingapore General Hospital
Singapore, Singapore
RECRUITINGNational Cancer Centre Singapore
Singapore, Singapore
NOT_YET_RECRUITINGEfficacy as measured by event free survival measured at 3-years follow up of patients who have received ibrutinib
Event-free survival is defined as time from diagnosis until relapse or progression, unplanned re-treatment of lymphoma after initial immunochemotherapy, or death as a result of any cause.
Time frame: 3 years
Progression-free survival
Progression-free survival is defined as the time from enrolment to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier.
Time frame: 3 years
Overall survival
Overall survival is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time frame: 3 years
Percentage of patients who have increased response from partial remission to complete remission ibrutinib before transplant
Reported as percentage of patients achieving a complete remission of the total patients starting ibrutinib.
Time frame: 6 weeks
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Raffles Hospital Singapore
Singapore, Singapore
NOT_YET_RECRUITING