EUCTR2015-004454-17-IT进行中（未招募）1 期
A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator¿s Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia - A Clinical trial to compare Acalabrutinib (ACP-196) versus investigator's choice standard treatment
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 306
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men and women = 18 years of age.
- •2. ECOG performance status of 0 to 2.
- •3. Diagnosis of CLL that meets published diagnostic criteria (Hallek 2008):
- •a. Monoclonal B-cells (either kappa or lambda light chain restricted) that are clonally co-expressing = 1 B-cell marker (CD19, CD20, or CD23) and CD5.
- •b. Prolymphocytes may comprise = 55% of blood lymphocytes.
- •c. Presence of = 5 x 109 B lymphocytes/L (5000 µL) in the peripheral blood (at any point since diagnosis).
- •4.Must have documented CD20-positive CLL.
- •5.Active disease meeting = 1 of the following IWCLL 2008 criteria for requiring treatment:
- •a. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelets < 100,000/µL).
- •b. Massive (ie, = 6 cm below the left costal margin), progressive, or symptomatic splenomegaly.
- •c. Massive nodes (ie, = 10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy.
- •d. Progressive lymphocytosis with an increase of > 50% over a 2-month period or a LDT of < 6 months. LDT may be obtained by linear regression extrapolation of ALC obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In subjects with initial blood lymphocyte counts of < 30 x 109/L (30,000/µL), LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infections) should be excluded.
- •e. Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy.
- •f. Constitutional symptoms documented in the subject’s chart with supportive objective measures, as appropriate, defined as = 1 of the following disease- related symptoms or signs:
- •i. Unintentional weight loss = 10% within the previous 6 months before screening.
- •ii. Significant fatigue (ECOG performance score 2 ; inability to work or perform usual activities).
- •iii. Fevers higher than 100.5°F or 38.0°C for = 2 weeks before screening without evidence of infection.
- •iv. Night sweats for > 1 month before screening without evidence of infection.
- •6. Meet the following laboratory parameters:
- •a. Absolute neutrophil count (ANC) = 750 cells/µL (0.75 x 109/L), or = 500 cells/µL (0.50 x 109/L) in subjects with documented bone marrow involvement, and independent of growth factor support 7 days before assessment.
- •b. Platelet count = 50,000 cells/µL (50 x 109/L), or = 30,000 cells/µL
- •(30 x 109/L) in subjects with documented bone marrow involvement, and without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be = 75,000 cells/µL (75 x 109/L).
- •c. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.0 x upper limit of normal (ULN).
- •d. Total bilirubin = 1.5 x ULN.
- •e. Estimated creatinine clearance of = 30 mL/min, calculated using the formula of Cockcroft and Gault [(140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female].
- •7.Must have received = 1 prior systemic therapies for CLL. Note: Single-agent steroids or localized radiation are not considered a prior line of therapy. If a single- agent anti-CD20 antibody was previously administered, subjects must have received = 2 doses.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of s
排除标准
- •1.Known CNS lymphoma or leukemia.
- •2.Known prolymphocytic leukemia or history of, or currently suspected, Richter’s syndrome.
- •3.Uncontrolled AIHA or ITP defined as declining hemoglobin or platelet count secondary to autoimmune destruction within the screening period or requirement for high doses of steroids (> 20 mg daily of prednisone daily or equivalent).
- •4.Prior exposure to a BCL-2 inhibitor (eg, venetoclax ABT-199) or a BCR inhibitor (eg, Btk inhibitors or PI3K inhibitors).
- •5.Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days before first dose of study drug.
- •6.Corticosteroid use > 20 mg within 1 week before first dose of study drug, except as indicated for other medical conditions such as inhaled steroid for asthma, topical steroid use, or as premedication for administration of study drug or contrast. For example, subjects requiring steroids at daily doses > 20 mg prednisone equivalent systemic exposure daily, or those who are administered steroids for leukemia control or white blood cell count lowering are excluded.
- •7.Prior radio- or toxin-conjugated antibody therapy.
- •8.Prior allogeneic stem cell transplant or prior autologous transplant within 6 months of first dose of study drug(s) or presence of graft-vs-host disease or recieving treatment for
- •graft-vs-host disease.
- •9.Major surgical procedure within 30 days of first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug.
- •10.History of prior malignancy except for the following:
- •a. Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening and felt to be at low risk for recurrence by treating physician.
- •b. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer.
- •c. Adequately treated carcinoma in situ without current evidence of disease.
- •11.Significant cardiovascular disease such as uncontrolled or untreated symptomatic arhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or QTc > 480 msec (calculated using Fridericia's formula: QT/RR0.33) at screening
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