The purpose of this study is to test the safety and any good and bad side effects of combining 2 study drugs, copanlisib and ibrutinib. This combination of drugs could shrink your Mantle Cell Lymphoma (MCL), but it could also cause side effects. Both these drugs have been given to people before, but this is the first time that they are being given together.
Description: using the RECIL criteriaMeasure: complete response (Phase II) Time: 2 years
There is one SNP
Inclusion Criteria: - Patient is ≥ 18 years of age at the time of signing Informed Consent - Patient is able and willing to adhere to the study visit schedule and other protocol requirements - Patient has histologically confirmed diagnosis of R/R mantle cell lymphoma who has received at least 1 line of therapy °Autologous stem cell transplant recipients must have adequate bone marrow recovery and transfusion independent - Patients may have been previously treated with BTK or PI3K inhibitors: °If BTK/P13K inhibitors were part of their last treatment, patients must have had a best response of stable disease or better - Patient has at least one measurable lesion (≥ 2 cm) according to RECIL criteria - Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 - Patient has adequate bone marrow and organ function by: - Absolute neutrophil count (ANC) ≥ 1 x 10^9/L , independent of growth factor support for 14 days unless there is bone marrow involvement. --- P13K ---
- Lipase ≤ 1.5x ULN - LVEF ≥ 50% - Hemoglobin A1c ≤ 8.5% Exclusion Criteria: - Patient has a history of non-compliance to medical regimen or inability to grant consent - Patient is concurrently using other approved or investigational antineoplastic agent with the exception of BTK or Pi3K inhibitors in patients who had these agents as the last line of treatment °Patient on BTK or P13K inhibitors will be continued on therapy as they transition to protocol therapy - Patient has not recovered to Grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy - Patient has had major surgery or a wound that has not fully healed within 4 weeks of starting study drugs. --- P13K ---