Obinutuzumab in Combination With Ibrutinib in Treating Patients With Relapsed Mantle Cell Lymphoma

Inclusion Criteria

• Subjects must have a diagnosis of relapsed or refractory mantle cell lymphoma as follows:
• Diagnosis of mantle cell lymphoma (MCL) must include morphology and expression of either cyclin D1 in association with other relevant markers (eg, CD19, CD20, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR)
• Relapsed or refractory disease is defined as no response or progressive disease to prior treatment if the prior treatment comprised any of the following:
• 1 regimen containing an anti-CD20 antibody administered for >= 2 doses, and/or
• >= 1 regimen containing 1 cytotoxic agent (e.g., bendamustine, chlorambucil, cyclophosphamide, cytarabine, doxorubicin) administered for 2 cycles
• At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma (Cheson Criteria); the site of disease must be greater than 1.5 cm in the long axis regardless of short axis measurement or greater than 1.0 cm in the short axis regardless of long axis measurement, and clearly measurable in 2 perpendicular dimensions
• Eastern Cooperative Oncology Group (ECOG) performance status = = 60%)
• Absolute neutrophil count (ANC) >= 1.0 K/cu mm; for subjects with ANC .5 K/cu mm
• Platelets (plt) >= 50 K/cu mm; for subjects with plt 25 K/cu mm
• Total bilirubin = = 2 years
• Adequately treated non-melanoma skin cancer or melanoma in situ without evidence of disease
• Adequately treated cervical carcinoma in situ without evidence of disease
• Asymptomatic prostate cancer managed with "active surveillance"
• Localized prostate cancer treated with definitive treatment including radiation or surgery. Patients on adjuvant hormone deprivation treatment such as lupron are eligible. Patients with known metastatic disease are ineligible
• History of stroke or intracranial hemorrhage within 6 months prior to randomization
• Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon)
• Vaccinated with live, attenuated vaccines within 4 weeks of randomization
• Requires treatment with strong cytochrome P450 3A (CYP3A) inhibitors
• Subjects who have had standard cytotoxic chemotherapy or radiotherapy within 3 weeks prior to entering the study or those whose adverse events due to agents administered more than 3 weeks earlier have not recovered to = 14 days are ineligible; no drug intervention or cessation is required for patients already receiving ibrutinib prior to initiation of on-study therapy
• Active graft versus (vs.) host disease (GVHD)
• Ongoing glucocorticoids (prednisone > 10 mg daily, or equivalent); higher doses (> 10 mg daily) are permitted for up to 5 days to help control disease related symptoms