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
Diffuse Large B-Cell Lymphoma,
Diffuse Large B-Cell Lymphoma Recurrent,
diffuse large cell lymphoma,
diffuse large b cell lymphoma,
Diffuse Large B-Cell Lymphoma Recurrent
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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