Carfilzomib and TGR-1202 in Treatment of R/R Lymphoma

Target Population Phase I: Patients with relapsed or refractory NHL and HL Phase II: Patients with relapsed or refractory NHL

Inclusion Criteria:

Phase I: Patients must have histologically confirmed R/R NHL or HL (defined by World Health Organization (WHO) criteria). Patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are eligible. In addition, patients with NHL other than diffuse large B cell lymphomas (DLBCL) must have received at least 2 prior therapies. Patients with DLBCL and HL will be eligible if there is no available standard therapy.
Phase II: Patients must have histologically confirmed R/R NHL (as defined by WHO criteria). Patients with NHL other than diffuse large B cell lymphomas (DLBCL) must have received at least 2 prior therapies. Patients with DLBCL will be eligible if there is no available standard therapy.
Must have received front line chemotherapy. No upper limit for the number of prior therapies
Evaluable Disease in the Phase I, and measurable disease in the Phase II
Age > 18 years
Eastern Cooperative Oncology Group (ECOG) performance status < 2
Patients must have adequate organ and marrow function
Adequate Contraception
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Prior Therapy Exposure to chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. Systemic steroids that have not been stabilized (≥ 5 days) to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs. No other investigational agents are allowed.
History of allergic reactions to TGR-1202 or carfilzomib
Uncontrolled inter-current illness
Pregnant women
Nursing women
Current malignancy or history of a prior malignancy
Patient known to be Human Immunodeficiency Virus (HIV)-positive
Active Hepatitis A, Hepatitis B, or Hepatitis C infection