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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.
|Leukemia, Chronic Lymphocytic (CLL)
- The primary objective of the Phase 1b study is to determine a safe and tolerable dose of TRU-016 that can be used in combination with bendamustine in patients with relapsed CLL. The primary objective of the Phase 2 study is to compare the efficacy and safety of TRU-016 in combination with bendamustine to bendamustine alone.
- A secondary objective is to compare the PK and PD results of different doses of TRU-016 with bendamustine. Additional secondary objectives are exploratory and involve response by baseline disease and patient characteristics.
- 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).18
- 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.
- The presence of at least one of the following criteria for active disease requiring treatment:
- Progressive splenomegaly and/or lymphadenopathy.
- Anemia (hemoglobin < 11 g/dL) or thrombocytopenia (platelets < 100 x 109/L or < 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.
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 (Appendix G).
- Life expectancy greater than 6 months in the opinion of the Investigator.
- 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).
- Creatinine clearance of > 40 mL/min as calculated by the Cockgroft and Gault method. (Creatinine clearance (mL/min) = (140 - age) x (weight in kg) x [0.85 if female] / 72 x Serum Creatinine (mg/dL)).
- ANC ≥1,200/mm3 (≥1,200/µL)
- Platelets ≥75,000/mm3 (≥75,000/µL).
- Lymphocytes ≥5,000/mm3 (≥5,000/µL) for Phase 1b; no requirement for Phase 2.
- Patient must be capable of understanding and providing written, voluntary informed consent.
- 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. Note: See Appendix L for specific requirements for the German CLL Study Group.
- 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.
- 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.
- Refractory to prior 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.
- Received prior bendamustine or TRU-016.
- Received an investigational therapy within 30 days before first study drug dose or has not fully recovered from any toxic effect of that therapy.
- Had major surgery within 30 days before first study drug dose.
- 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.
- 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.
- Positive serology for human immunodeficiency virus (HIV) or hepatitis C.
- 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.
- Pregnant or breast feeding; women of childbearing potential must have a negative pregnancy test prior to treatment.
- Allergic to mannitol.
- Known current drug or alcohol abuse.
- 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.
- Any difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration or may interfere with safety.
- Any circumstance at the time of study entry that would preclude completion of the study.
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