Diffuse Large B Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of Ibrutinib With R-ICE Chemotherapy for Transplant-eligible Relapsed/Refractory Diffuse Large B-cell Lymphoma Followed by Ibrutinib Maintenance in Patients Not Achieving a Complete Response at Pre-transplant Interim Assessment
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.
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