CTRI/2021/04/033224已完成4 期
A prospective, multi-centre, phase IV clinical trial to assess the safety and efficacy of Acalabrutinib capsules in Indian adult patients with chronic lymphocytic leukaemia and relapsed and refractory mantle cell lymphoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 103
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
入选标准
- •1.Men and Women aged 18yrs or more.
- •2.Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2
- •3.Able to receive all outpatient treatments, all laboratory monitoring, and all radiologic evaluations.
- •4.The following laboratory parameters:
- •a.Absolute neutrophil count (ANC) =750 cells/µL or =500 cells/µL in patients with documented bone marrow involvement, and independent of growth factor support 07 days before the assessment
- •b.Platelet count =50,000 cells/µL or =30,000 cells/µL in patients with documented bone marrow involvement, and without transfusion support 07 days before the assessment
- •c.Aspartate transaminase (AST) and Alanine transaminase (ALT) =2.0 x ULN
- •d.Total bilirubin =1.5 x ULN
- •e.Estimated creatinine clearance of =30 mL/min
- •5.Refractory disease defined as achieving less than partial response with the most recent treatment within 6 months before study entry
- •6.Provision of signed, written and dated informed consent prior to any study-specific Procedures.
- •7.The patients of either CLL or MCL:
- •a.CLL patients:
- •i. Treatment naïve or =1 prior systemic therapy for CLL
- •ii. Diagnosis of CD20+ CLL that meets published diagnostic criteria (Hallek et al. 2018)
- •iii. An active disease that meets =1 of the following iwCLL 2018 criteria for requiring treatment:
- •1) Evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia. Cut-off levels of Hb <10 g/dL or platelet counts <100 × 109/L are generally regarded as an indication for treatment. However, in some patients, platelet counts <100 × 109/L may remain stable over a long period; this situation does not automatically require therapeutic intervention.
- •2) Massive (i.e., =6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
- •3) Massive nodes (i.e., =10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
- •4) Progressive lymphocytosis with an increase of =50% over a 2-month period or Lymphocyte Doubling Time (LDT) in <6 months. LDT can be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months; patients with initial blood lymphocyte counts <30 × 109/L may require a longer observation period to determine the LDT. Factors contributing to lymphocytosis other than CLL (e.g., infections, steroid administration) should be excluded.
- •5) Autoimmune complications, including anaemia or thrombocytopenia poorly responsive to corticosteroids.
- •6) Symptomatic or functional extra-nodal involvement (e.g., skin, kidney, lung, spine).
- •7) Disease-related symptoms as defined by any of the following:
- •a) Unintentional weight loss of =10% within the previous 06 months.
- •b) Significant fatigue (i.e., ECOG performance scale 02 or worse; cannot work or unable to perform usual activities).
- •c) Fever =100.5°F or 38.0°C for 02 or more weeks without evidence of infection.
- •d) Night sweats for =1 month without evidence of infection.
- •b.MCL Patients:
- •i. Confirmed MCL with translocation t(11;14) (q13;q32) and/or overexpressed cyclin D1
- •ii. Measurable nodal disease (one or more lesions measuring =2 cm in the longest diamete
排除标准
- •1.Known prolymphocytic leukaemia, Central Nervous System (CNS) lymphoma or leukaemia; or known history of (or currently suspected) Richter’s syndrome
- •2.Treatment with chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days of the first dose of study drug
- •3.Prior radio-conjugated or toxin-conjugated antibody therapy
- •4.Anticoagulation therapy (e.g., warfarin or equivalent vitamin K antagonists) within 07 days of the first dose of study drug.
- •5.Major surgery =30 days before the first dose of study drug
- •6.History of stroke or intracranial haemorrhage =6 months before the first dose of study drug
- •7.History of bleeding diathesis
- •8.Prior exposure to a B-cell lymphoma-2 (Bcl-2) inhibitor or B-cell receptor inhibitor like BTKs
- •9.Active Cytomegalovirus (CMV) infection or serologic status reflecting active Hepatitis B or C infection or known history of infection with Human Immunodeficiency Virus (HIV), or any uncontrolled active systemic infection.
- •10.Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, Congestive Heart Failure, or Myocardial Infarction within 06 months of screening, or any Class 3 or 4 cardiac diseases as defined by the New York Heart Association Functional Classification, or QTcB >480 msec at screening.
- •11.Requiring treatment with proton-pump inhibitors (e.g., Omeprazole, Esomeprazole, Lansoprazole, Dexlansoprazole, Rabeprazole, or Pantoprazole).
- •12.Breastfeeding or pregnant.
- •13.Current life-threatening illness, medical condition, or organ/system dysfunction which, in the Investigator’s opinion, could have compromised the subject’s safety or put the study at risk.
- •14.Concurrent participation in another therapeutic clinical trial.
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