Ofatumumab Early Treatment for High-Risk Treatment-Naive, Early Stage (0-II) Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of Patients With Complete Response (CR)
研究概览
简要总结
The goal of this clinical research study is to learn if ofatumumab can help to control CLL/SLL that has not yet been treated. The safety of this drug will also be studied.
详细描述
The Study Drug:
Ofatumumab is designed to bind to the surface of some of the white blood cells (B-cells). It may destroy cancer cells that come from B-cells.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive a "loading dose" (a lower dose given first, to lower the risk of a bad reaction to the study drug) of ofatumumab by vein on Day 1 of Cycle 1. The loading dose is less than one-third (1/3) of the normal dose. You will then receive the normal dose over 4 hours 1 time each week (+/- 3 days). The doses may be given more slowly, if your doctor thinks it is needed. All doses of the study drug will be given at M. D. Anderson.
Benadryl (diphenhydramine) and glucocorticoids (steroids such as prednisolone) will be given by vein 30 minutes to 2 hours before you receive ofatumumab to help prevent side effects. You will also take pills of acetaminophen (Tylenol) to help prevent side effects. If no side effects occur, these "pre-medications" may be reduced or not given after the second infusion.
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
- •Diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL), previously untreated, Rai stage 0-ll
- •At least 1 of the following high-risk features for previously untreated patients: Rai stage II disease; Rai stage 0-I with disease-related fatigue; Serum beta2M >/= 3 mg/L; Absolute lymphocyte count >/= 25,000/uL; Unmutated IGHV gene or IGHV3-21; ZAP70 positive (>/= 20% by flow cytometry or positive by immunohistochemistry); CD38 positive (>/= 30% by flow cytometry); OR Deletion 11q or 17p by FISH
- •ECOG PS </= 2
- •Age >/= 18 years
- •Patients must have adequate renal and hepatic function (creatinine <2mg/dL, total bilirubin <2mg/dL). Patients with renal or liver dysfunction due to organ infiltration with CLL may be eligible after discussion with the study chairman
- •Provide informed consent
- •Female patients (including those < 1 year post-menopausal) and male patients who have not undergone previous surgical sterilization must agree to use contraception.
排除标准
- •Presence of 2008 IWCLL/NCI-WG indication for CLL treatment: Constitutional symptoms related to CLL/SLL: Fever > 100.5 degrees F for >/= 2 weeks or night sweats for > 1 mo, both without evidence of infection; Unintentional weight loss of >/= 10% body weight in previous 6 months; Extreme fatigue (ECOG PS > 2; inability to work or perform usual activities); Lymphocyte doubling time of </= 6 months or 50% increase in absolute lymphocyte count within 2 months; Progressive anemia (Rai stage III) or thrombocytopenia (Rai stage IV); Recurrent infections unrelated to hypogammaglobulinemia; Autoimmune phenomenon poorly responsive to corticosteroids or other standard therapy; Massive, progressive or symptomatic lymphadenopathy (> 10 cm in longest diameter) or splenomegaly (> 6 cm below left costal margin)
- •Prior or concurrent chemotherapy, radiotherapy, or immunotherapy for CLL
- •Active infection (febrile and requiring IV/PO antibiotics), including hepatitis C or HIV, or significant medical illness including renal, cardiac, pulmonary disease, or current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- •Positive serology for Hepatitis B virus (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the patient will be excluded. -- Consult with a physician experienced in care and management of subjects with hepatitis B to manage/treat subjects who are anti-HB positive.
- •Pregnant or breast feeding females are not eligible.
研究组 & 干预措施
Ofatumumab
Loading dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses).
干预措施: Ofatumumab (Drug)
结局指标
主要结局
Number of Patients With Complete Response (CR)
时间窗: Up to 12 years
2008 International Workshop on CLL (IWCLL) update of the National Cancer Institute-sponsored Working Group (NCI-WG) outlined specific criteria of Complete Response (CR) for diagnosing CLL. CR is defined as Marrow normocellular, no CLL cells, no B-lymphoid nodules, hemoglobin of ≥11.0 g/dL (untransfused and without erythropoietin), Platelet count of ≥100 × 10\^9/L, circulating lymphocyte count normal, no constitutional symptoms, Liver and/or spleen size \<13 cm; liver size normal, lymph nodes ≥ 1.5 cm.
次要结局
未报告次要终点