EUCTR2010-019554-41-DE进行中（未招募）不适用
A Phase 1b/2 Open Label Study to Evaluate the Safety and Efficacy of TRU-016 in Combination with Bendamustine vs. Bendamustine Alone in Patients with Relapsed Chronic Lymphocytic Leukemia
Emergent Product Development Seattle, LLC0 个研究点目标入组 78 人开始时间: 2011年5月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Previously treated patients with a diagnosis of CLL by the 2008 International Working Group Criteria (Appendix C)21 and with Rai stage intermediate or high risk CLL (Appendix D).
- •2. Refractory or relapsed disease after at least one prior treatment and no more than 3 prior
- •treatments. Patients with repeated treatment regimens of either single agent chlorambucil or
- •single agent rituximab will count as only 1 prior treatment regimen for each drug. If a patient is discontinued from a treatment regimen or drug within 2 cycles secondary to toxicities then that regimen or drug will not count as a prior treatment regimen.
- •3. The presence of at least one of the following criteria for active disease requiring treatment:
- •Progressive splenomegaly and/or lymphadenopathy.
- •<100,000/mm3) due to bone marrow involvement.
- •Progressive lymphocytosis with an increase of >50% over a 2-month period or an anticipated doubling time of less than 6 months.
- •4. Age =18 years.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of =2 (Appendix G).
- •6. Life expectancy greater than 6 months in the opinion of the Investigator.
- •7. Serum creatinine, total bilirubin, serum glutamic oxaloacetic transaminase (SGOT) or aspartate
- •aminotransferase (AST), serum glutamate pyruvate transaminase (SGPT) or alanine
- •aminotransferase (ALT) of =2.0 x upper limit of normal (ULN).
- •8. Creatinine clearance of >40 mL/min as calculated by the Cockgroft and Gault method.23
- •Creatinine clearance (mL/min) = (140 – age) x (weight in kg) x [0.85 if female]
- •72 x Serum Creatinine (mg/dL)
- •9. ANC =1,200/mm3 (=1,200/µL)
- •10. Platelets =75,000/mm3 (=75,000/µL). For platelets receiving platelet infusions, the most recent infusion must be at least 30 days prior to Screening.
- •11. Lymphocytes =5,000/mm3 (=5,000/µL) for Phase 1b; no requirement for Phase 2.
- •12. Patient must be capable of understanding and providing written, voluntary informed consent.
- •13. Both women of child-bearing potential and male patients must use an acceptable form of birth control for the duration of their study participation and for 6 months after completing study drug dosing. Acceptable forms of birth control include, unless dictated otherwise by local regulatory authorities, consistent abstinence from heterosexual activity; consistent use of combined or
- •progestogen oral contraceptives; injectable progestogen; implants of levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches or intrauterine device (IUD); vasectomy with
- •documented azoospermia >6 months of the sole male partner, hysterectomy, tubal ligation or double-barrier method (condom or occlusive cap plus spermicidal agent). Male subjects must not donate sperm during the study and for 6 months after completing study drug dosing.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 78
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 78
排除标准
- •1. Received treatment with rituximab or other B-cell depleting agent within 30 days before first study drug dose or alemtuzumab within 12 weeks before first study drug dose.
- •2. Received previous anticancer therapy within 30 days before first study drug dose and/or has not
- •fully recovered from the toxic effects of that treatment.
- •3. Refractory to prior bendamustine, fludarabine or other purine analog therapy; either as single agent or in
- •combination. Refractory is defined as failed to respond to therapy (did not achieve CR or PR) or
- •relapsed <6 months after treatment completed. Patients who discontinued prior bendamustine secondary to toxicities (i.e. prolonged neutropenia >4 weeks) are excluded.
- •4. Received prior TRU-016.
- •5. Received an investigational therapy within 30 days before first study drug dose or has not fully
- •recovered from any toxic effect of that therapy.
- •6. Had major surgery within 30 days before first study drug dose.
- •7. Previous or concurrent additional malignancy except noninvasive, nonmelanomatous skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, or currently
- •controlled (in remission or on hormonal therapy, e.g. prostate or breast cancer) with estimated survival in excess of 2 years. These cases must be discussed with the Medical Monitor before
- •enrollment.
- •8. Any significant concurrent medical diseases or conditions, including:
- •Clinically significant pulmonary dysfunction requiring oxygen therapy.
- •Active infection (viral, bacterial, or fungal) requiring systemic therapy. Patients who are on
- •prophylactic therapy are eligible.
- •Prior allogeneic bone marrow transplant.
- •Active autoimmune disease requiring immunosuppressive therapy. If the patient has an autoimmune complication secondary to CLL and it is controlled by immunosuppressive
- •therapy then the patient may be enrolled. If the disease is active and uncontrolled with
- •medication then they are to be excluded. If the patient has autoimmune disease not related to CLL they may not be enrolled if they are on any immunosuppressive therapy.
- •9. Positive serology for human immunodeficiency virus (HIV) or hepatitis C.
- •10. Hepatitis B surface antigen positive or hepatitis B core antibody positive. Patients positive for
- •hepatitis B surface antibody may be enrolled if both hepatitis B surface antigen and hepatitis B core antibody are negative. If the hepatitis B core antibody is the only test positive and it is the result of immunoglobulin treatment, the patient may be enrolled if the HBV DNA is negative.
- •11. Pregnant or breast feeding; women of childbearing potential must have a negative pregnancy test prior to treatment.
- •12. Allergic to mannitol.
- •13. Known current drug or alcohol abuse.
- •14. Any severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or other
- •condition, which in the judgement of the Investigator would place the subject at undue risk,
- •interfere with the results of the study or make the patient otherwise unsuitable.
- •15. Any difficulty complying with protocol requirements that may increase the risk associated with
- •study participation or study drug administration or may interfere with safety.
- •16. Any circumstance at the time of study entry that would preclude completion of the study.
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