Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: CT-011; Rituximab
Intervention description: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days).; Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
Intervention MeSH terms: Rituximab; Pidilizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Follicular lymphoma; Immunotherapy; CT-011; Monoclonal Antibody CT-011; Rituximab; Rituxan

Summary:

      The goal of this clinical research study is to learn if the combination of the immunotherapy
      drugs, CT-011 and rituximab, can help control follicular lymphoma. The safety of this drug
      combination will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with histologic proof of follicular lymphoma grade 1 or grade 2 relapsing
             after at least 1 but no more than 4 prior systemic therapies.Patients may have had
             prior local radiation therapy in addition to up to 4 prior systemic therapies. History
             of total body irradiation will be considered as prior systemic therapy.

          2. If patient received prior rituximab-based therapy, should have rituximab sensitive
             disease defined as a complete or partial response of at least 6 months duration with
             the rituximab-based regimen.

          3. Patients must be >= 18 years of age.

          4. Should have measurable (>= 1.5 cm) disease.

          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          6. At least 4 weeks from last chemotherapy, immunotherapy, radiation therapy, monoclonal
             antibody therapy, or experimental therapy and must have recovered from acute toxic
             effects of prior therapy.

          7. Absolute neutrophil count >= 1.5 × 10^9/L.

          8. Platelets >= 50 × 10^9/L.

          9. Absolute lymphocyte count >= 0.6 × 10^9/L.

         10. Adequate renal function with creatinine <= 1.5 × the upper limit of normal (ULN).

         11. Adequate hepatic function with total bilirubin <= 1.5 mg/dL; AST and ALT <= 2.5 × ULN.

         12. Women of child-bearing potential (i.e., woman has not been naturally postmenopausal
             for at least 24 consecutive months or not surgically sterile) and sexually active men
             must agree to use 2 acceptable contraceptive methods during this study. One of the 2
             methods of birth control must be a condom. Acceptable methods of birth control in
             combination with condoms include diaphragm, birth control pills, injections,
             intrauterine device, and/or under-the-skin implants. Men and women must agree to
             maintain effective contraception for up to 3 months after the last dose of drug is
             administered.

         13. Patients must sign an informed consent indicating that they are aware of the
             investigational nature of this study.

        Exclusion Criteria:

          1. Patients positive for HIV, hepatitis B surface antigen, or hepatitis C antibody.

          2. Patients requiring concurrent immunosuppressive therapy are excluded. Inhaled or
             topical steroids for treating mild to moderate respiratory illnesses, allergies, skin
             rashes or ocular inflammations are allowed.

          3. History of central nervous system (CNS) lymphoma.

          4. Active or history of autoimmune disease except Hashimoto's thyroiditis. Patients with
             type I diabetes mellitus are excluded.

          5. Active infection or other serious intercurrent medical illness

          6. New York Heart Association Class III or IV disease.

          7. Pregnant or nursing.

          8. History of allogeneic stem cell transplantation.

          9. Other concurrent chemotherapy, radiotherapy, immunotherapy, or investigational therapy

         10. Any other malignancy except basal or squamous cell carcinoma of the skin, or cervical
             carcinoma in situ treated with curative intent. Any cancer from which the patient has
             been disease free for at least 5 years is permissible.

         11. Any underlying medical condition which, in the Principal Investigator's opinion, will
             make the administration of study drug hazardous or obscure the interpretation of
             adverse events.