Acalabrutinib Study in Indian Patients With Chronic Lymphocytic Leukaemia & Relapsed and Refractory Mantle Cell Lymphoma
Source: ClinicalTrials.gov NCT04930536 ↗No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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 | — |
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. Informational only — not medical advice.