Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in combination with Rituximab in Patients with Relapsed Follicular Lymphoma
CT-011 Monoclonal Antibody,Rituximab
Sattva S. Neelapu
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.
Disease Group: Lymphoma
Treatment Agent: CT-011 Monoclonal Antibody,Rituximab
Treatment Location: Only at MD Anderson
Estimatated Length of Stay in Houston: N/A
Sponsor: Cure Tech Ltd
Return Visit: Pre-treatment, days 1, 2, 7, 14, 17, 24, 29, 31, 38, 43, 57, 85, and weeks 16, 20, 24, 28, 32, 36, 40, 44, 52, 64, 76, 88, 100, 112, and 124.
Home Care: N/A
Primary Objective To determine the overall response rate. Secondary Objectives To determine the safety and toxicity To determine the complete response rate To determine the time to progression To determine whether administration of CT-011 enhances the function of tumor-specific T cells and natural killer cells To evaluate the immunogenicity and pharmacokinetics of CT-011
IRB Review and Approval Date: 01/08/2010
Recruitment Status: Not Accepting
Projected Accrual: N/A
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) 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.
1) Patients positive for HIV, hepatitis B surface antigen, or hepatitis
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 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.
Information and next steps
Sattva S. Neelapu
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