- Mantle cell lymphoma (MCL) confirmed with histology, immunophenotype, and cyclin D1
analysis
- Received 2 to 7 prior therapies which may include hematopoietic stem cell transplant
(i.e. induction + consolidation + maintenance)
- Prior treatment with an alkylating agent and an anthracycline, rituximab, individually
or in combination, and status that is at least one of the following:
- Primary disease refractory to at least 2 regimens;
- Refractory to at least 1 regimen after first relapse;
- Refractory or untreated after second or greater relapse;
- Refractory to first line and relapsed after second line. Chemotherapy combinations may
include, but are not limited to: CHOP (Cyclophosphamide, doxorubicin, vincristine,
prednisone), R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine,
prednisone), FCM (Fludarabine, cyclophosphamide, mitoxantrone), R-FCM
(Rituximab,Fludarabine, cyclophosphamide, mitoxantrone), ICE(Ifosfamide, carboplatin,
etoposide), DHAP (Dexamethasone, cisplatin, cytarabine) and hyper-CVAD
(Cyclophosphamide, doxorubicin, vincristine, dexamethasone).
- Subjects who are less than or equal to six month from allogeneic hematopoietic stem
cell transplant and who are on immunosuppressive therapy or have evidence of graft
versus host disease
- Prior investigational therapy within 3 weeks of first dose. Investigational therapy is
defined as treatment that is not approved for any indication.
- Active central nervous system (CNS) metastases, as indicated by clinical symptoms,
cerebral edema, requirement for corticosteroids and/or progressive growth. (Treated
CNS metastases must be stable for > 2 weeks prior to Day 1.)