Health Condition 1: C911- Chronic lymphocytic leukemia of B-cell type Health Condition 2: C831- Mantle cell lymphoma
Conditions
Interventions
Intervention1: Acalabrutinib: Study treatment name: Acalabrutinib
Dosage formulation: Capsule
Route of administration: Per Oral(PO)
Dosing instructions :The recommended dose is 100 mg (1 capsule) twice daily. Acalabrutinib should be swallowed whole with water at approximately the same time each day. Acalabrutinib can be taken with
Sponsors
AstraZeneca Pharma India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 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 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the safety of Acalabrutinib among patients with treatment naïve and R/R CLL/ SLL, and relapsed & refractory MCL in Indian patientsTimepoint: Screening visit to 28 days after the last Acalabrutinib dose in the treatment phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy of Acalabrutinib in patients of CLL/SLL and relapsed & refractory MCL in Indian patients. Patient-reported outcome (PRO) Timepoint: Baseline Three Month Visit 8 (Day 170) End of Treatment Visit | — |
Countries
India
Contacts
Public ContactAmit Kumar
AstraZeneca Pharma India Ltd
Outcome results
None listed