Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
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.
详细描述
The Study Drugs:
Rituximab is designed to attach to lymphoma cells, which may cause them to die.
CT-011 is designed to strengthen the immune system against cancer, possibly helping the immune cells kill the lymphoma cells better.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive an infusion of CT-011 every 4 weeks for a total of 4 infusions. The first infusion will take at least 2 hours and will be given through a needle in your vein. Later infusions will take at least 1 hour. You must stay at the hospital for 2 hours after each infusion. If the lymphoma remains stable or is shrinking after 4 infusions of CT-011, you may receive 8 additional infusions of CT-011 every 4 weeks, for a total of 12 infusions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
- •Patients must be >= 18 years of age.
- •Should have measurable (>= 1.5 cm) disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •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.
- •Absolute neutrophil count >= 1.5 × 10^9/L.
- •Platelets >= 50 × 10^9/L.
- •Absolute lymphocyte count >= 0.6 × 10^9/L.
- •Adequate renal function with creatinine <= 1.5 × the upper limit of normal (ULN).
- •Adequate hepatic function with total bilirubin <= 1.5 mg/dL; AST and ALT <= 2.5 × ULN.
- •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.
- •Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
排除标准
- •Patients positive for HIV, hepatitis B surface antigen, or hepatitis C antibody.
- •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.
- •History of central nervous system (CNS) lymphoma.
- •Active or history of autoimmune disease except Hashimoto's thyroiditis. Patients with type I diabetes mellitus are excluded.
- •Active infection or other serious intercurrent medical illness
- •New York Heart Association Class III or IV disease.
- •Pregnant or nursing.
- •History of allogeneic stem cell transplantation.
- •Other concurrent chemotherapy, radiotherapy, immunotherapy, or investigational therapy
- •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.
- •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.
研究组 & 干预措施
CT-011 in combination with Rituximab
Combination of the immunotherapy drugs, CT-011 and rituximab.
干预措施: CT-011 (Drug)
CT-011 in combination with Rituximab
Combination of the immunotherapy drugs, CT-011 and rituximab.
干预措施: Rituximab (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Response measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.
Overall response (OR) rate defined as complete response (CR) + partial response (PR). CR: Complete disappearance of all detectable clinical evidence of disease and symptoms if present before therapy. If a PET scan was positive before therapy, a post-treatment residual mass of any size was deemed a complete response provided that it was PET negative. If response was determined by CT scan criteria, lymph nodes that regressed to less than 1·5 cm were deemed to be complete response. The spleen and/or liver, if considered enlarged before therapy should not be palpable on physical examination and be considered normal size by imaging studies, and nodules related to lymphoma should disappear. PR: At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by ≥ 50% in their SPD. No new sites of disease should be observed.
次要结局
- Progression-Free Survival(Measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.)