EUCTR2015-004454-17-BE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
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 initial 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 (i.e., = 6 cm below the left costal margin), progressive, or symptomatic splenomegaly.
- •c. Massive nodes (i.e., = 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 (e.g., 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.
- •8.Women who are sexually active and can bear children must agree to use highly effective forms of contraception w
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 or equivalent).
- •4.Prior exposure to a BCL-2 inhibitor (e.g., venetoclax/ABT-199) or a BCR inhibitor (e.g, 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 daily prednisone equivalent 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 admin 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 receiving treatment for graft-vs-host disease.
- •9.Major surgical procedure within 30 days of 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 arrhythmias, 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 corrected QT interval (QTc) > 480 msec (calculated using Fridericia’s formula: QT/RR0.33) at screening.
- •12.Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach, or extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass
- •13.Received a live virus vaccination within 28 days of first dose of study drug.
- •14.Known history of infection with HIV or any uncontrolled active systemic infection (e. g, bacterial, viral or fungal). For sites in Germany: active HIV infection(seropositivity for HIV-1 or HIV-2 antibodies, and if positive, reactivity against the HIV specific p24 antigen).
- •15.Active CMV infection (active viremia as evidenced by positive polymerase chain reaction [PCR] result for CMV DNA).
- •16.Serologic status reflecting active hepatitis B or C infection.
- •a. Subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative PCR result before randomization.
- •b.Subjects who are hepatitis C antibody positive will need to have a negative PCR result before randomization.
- •17.Ongoing,
研究者
相似试验
进行中（未招募）
1 期
This study is being done to test the effectiveness and safety of an investigational drug called acalabrutinib (ACP-196) when taken with already marketed drugs called Venetoclax and Obinutzumab in comparison to chemotherapy that is already in wide use for treatment of patients who have chronic lymphocytic leukemia and who have never been treated before.Previously untreated Chronic Lymphocytic Leukemia Without del(17p) or TP53 MutationMedDRA version: 21.0Level: LLTClassification code 10009310Term: CLLSystem Organ Class: 100000004864EUCTR2018-002443-28-ITACERTA PHARMA BV780
进行中（未招募）
1 期
This study is being done to test the effectiveness and safety of an investigational drug called acalabrutinib (ACP-196) when taken with already marketed drugs called Venetoclax and Obinutzumab in comparison to chemotherapy that is already in wide use for treatment of patients who have chronic lymphocytic leukemia and who have never been treated before.Previously untreated Chronic Lymphocytic Leukemia Without del(17p) or TP53 MutationMedDRA version: 21.0Level: LLTClassification code 10009310Term: CLLSystem Organ Class: 100000004864EUCTR2018-002443-28-DKAcerta Pharma B.V.780
进行中（未招募）
1 期
A Clinical trial to compare Acalabrutinib (ACP-196) versus investigator's choice standard treatment with Bendamustine/Rituximab or Idelalisib/Rituximab alone in patients with Relapsed or Refractory Chronic Lymphocytic LeukemiaRelapsed or Refractory Chronic Lymphocytic LeukemiaMedDRA version: 20.1Level: LLTClassification code 10008978Term: Chronic lymphocytic leukemia refractorySystem Organ Class: 100000004864EUCTR2015-004454-17-GBAcerta Pharma BV306
进行中（未招募）
不适用
A Randomized, Multicenter, Open-Label, Phase 3 Study of Gemcitabin-Cisplatin Chemotherapy Plus IMC-11F8 Versus Gemcitabin-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Squamous Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) - SQUIREAdvanced squamous non small cell lung cancerMedDRA version: 12.0Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIBMedDRA version: 12.0Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IVEUCTR2009-013838-25-GRImClone LLC947
进行中（未招募）
1 期
A Clinical trial to compare Acalabrutinib (ACP-196) versus investigator's choice standard treatment with Bendamustine/Rituximab or Idelalisib/Rituximab alone in patients with Relapsed or Refractory Chronic Lymphocytic LeukemiaRelapsed or Refractory Chronic Lymphocytic LeukemiaMedDRA version: 21.1Level: LLTClassification code 10008978Term: Chronic lymphocytic leukemia refractorySystem Organ Class: 100000004864EUCTR2015-004454-17-ITACERTA PHARMA BV306