Phase 4
N=103
Acalabrutinib Study in Indian Patients With Chronic Lymphocytic Leukaemia & Relapsed and Refractory Mantle Cell Lymphoma
Chronic Lymphocytic Leukemia and Relapsed and Refractory Mantle Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT04930536 ↗Enrolled (actual)
103
Serious AEs
11.0%
Results posted
Nov 2024
Primary outcome: Primary: Adverse Events of Special Interest (AESI) Including Arrhythmias (Atrial Fibrillation), Anaemia, Hypertension, Bleeding, Infections — 0; 0 Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Acalabrutinib capsule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events of Special Interest (AESI) Including Arrhythmias (Atrial Fibrillation), Anaemia, Hypertension, Bleeding, Infections |
0; 0 | — |
| PRIMARY Second Primary Malignancies |
0; 0 | — |
| SECONDARY Objective Response to Treatment |
1; 2; 53; 3; 1; 0 | — |
| SECONDARY Health Related Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQC30] Questionnaire) |
56.9; 57.0; 56.8; 57.9; 57.9; 58.6 | — |
Summary
This study is plan to assess the safety and efficacy of Acalabrutinib in Indian patients with chronic lymphocytic leukaemia (CLL) and relapsed and refractory mantle cell lymphoma (MCL)
Eligibility Criteria
Inclusion Criteria
Patients are eligible to be included in the study only if all of the following inclusion criteria and none of the exclusion criteria apply:
- 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.
- The following laboratory parameters:
- 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
- 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
- Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤2.0 x ULN
- Total bilirubin ≤1.5 x ULN
- 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:
- Evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia. Cut-off levels of Hb 480 msec at screening.
- Requiring treatment with proton-pump inhibitors (e.g., Omeprazole, Esomeprazole, Lansoprazole, Dexlansoprazole, Rabeprazole, or Pantoprazole).
- Breastfeeding or pregnant.
- 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.
- Concurrent participation in another therapeutic clinical trial.
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Data sourced from ClinicalTrials.gov (NCT04930536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.