Prior treatment with idelalisib;
Prior treatment with idelalisib
Documented evidence of resistance to prior treatment with idelalisib or other PI3K inhibitors.
Prior treatment with idelalisib
Prior treatment with idelalisib (a PI3K inhibitor).
Previous treatment with idelalisib at any time (ZYDELIG®)
Patients with prior treatment with idelalisib.
Has had prior treatment with idelalisib
For institutions that have Phase 3 or Phase 4 protocols studying idelalisib (Zydelig®) ; individuals with malignancies being studied in these protocols must have failed screening in the respective idelalisib protocol
Prior exposure to idelalisib
Prior therapy must include rituximab and alkylating agents.Prior exposure to idelalisib or other PI3K inhibitors is acceptable (except to copanlisib) provided that there is no resistance.
Idelalisib within 2 days prior to leukapheresis
IDELALISIB-SPECIFIC EXCLUSION CRITERIA
Ongoing drug-induced pneumonitis would be exclusion for idelalisib therapy but ibrutinib would be an option
Prior systemic chemotherapy treatment for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib single agent only)
Received one prior line of chemotherapy for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib + mFOLFOX6 only)
Hepatic: Total bilirubin ? 1.25 x upper limit of normal (ULN) (Arm: idelalisib + nab-paclitaxel ); total bilirubin ?1.5 x ULN (Arm: single agent idelalisib and Arm: idelalisib + mFOLFOX6); aspartate transaminase (AST) (SGOT), alanine transaminase (ALT) (SGPT) < 2.5 x ULN, and albumin > 3.0 g/dL
Presence of peripheral neuropathy ? Grade 2 (Arm: idelalisib + nab-paclitaxel and Arm: idelalisib + mFOLFOX6)
Prior therapy with idelalisib
Patients with hematologic malignancies completing a prior idelalisib study with a clinical benefit are eligible
Prior exposure to idelalisib